1. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for population sequencing and cancer, today announced that the U.S. Department of Veterans Affairs Million Veteran Program (VA MVP) has issued a new task order under its current contract with the company, with a value of up to approximately $10 million. The company also announced that it has received, so far in Q3, more than $25M in orders from its oncology customers, a new record. Together these orders allow the company to reconfirm its total revenue outlook for 2021, with oncology revenue growth now projected to be at least 50% above 2020.

    "We are extremely pleased with our on-going relationship with the VA MVP, which represents the largest whole genome sequencing project in the…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for population sequencing and cancer, today announced that the U.S. Department of Veterans Affairs Million Veteran Program (VA MVP) has issued a new task order under its current contract with the company, with a value of up to approximately $10 million. The company also announced that it has received, so far in Q3, more than $25M in orders from its oncology customers, a new record. Together these orders allow the company to reconfirm its total revenue outlook for 2021, with oncology revenue growth now projected to be at least 50% above 2020.

    "We are extremely pleased with our on-going relationship with the VA MVP, which represents the largest whole genome sequencing project in the United States," said John West, Chief Executive Officer. "Although this new task order is less than in pre-Covid years, we do expect this program to continue for many years to come, and to reaccelerate after the pandemic. In addition, our record oncology orders have largely offset the VA MVP order decline. Oncology orders received so far in Q3 have already exceeded the orders received in the first half of 2021, and are more than double our level in Q3 2020."

    Personalis has delivered over 140,000 whole human genomes to date, and with this new task order remains on track to reach its goal of 150,000 by the end of 2021. ​​ Personalis also takes advantage of this experience and infrastructure to offer whole genome sequencing in cancer, and expects this to be an increasingly important contributor to its business in the future.

    The performance period for the new VA MVP task order will be September 17, 2021 through March 31, 2022. Realizing revenue from this contract is subject to the receipt of samples from the VA MVP and performance of services by Personalis. The cumulative value of task orders received to date from the VA MVP has increased to approximately $185M. Following a pause during the pandemic, the VA MVP has resumed enrollment, now with approximately 840,000 veterans and the ultimate goal of enrolling two million.

    Some of the new oncology orders received are for prospective projects, which are expected to provide revenue over several years, compared with retrospective projects that may be completed in less than two years. The company now expects that its oncology business will become the larger portion of its total revenue in 2022 and, long-term, the company expects that it represents Personalis' largest market opportunity.

    Updated Business Outlook

    Personalis now expects the following for the third quarter of 2021:

    • Total revenue to be approximately $22.2 million (no change from previous outlook)
    • Revenue from biopharma and all other customers, excluding VA MVP, to be in the range of $8.3 million to $8.8 million (up from previous guidance of $7.5 million to $8.5 million)
    • Net Loss to be in the range of $17 million to $18 million; estimated outstanding shares of 44 million (no change from previous outlook)

    Personalis expects the following for the full year of 2021:

    • Total revenue to be approximately $85 million (no change from previous outlook)
    • Revenue from biopharma and all other customers, excluding VA MVP, to be in the range of $34 million to $35 million (up from previous guidance of $33 million to $34 million)
    • Net Loss to be in the range of $65 million to $70 million; estimated outstanding shares of 44 million (no change from previous outlook)

    The company is not providing a business outlook for fiscal year 2022 at this time. However, the company is targeting approximately 50% growth in biopharma and other customer (excluding VA MVP) revenue for the full year 2022.

    Webcast and Conference Call Information

    Personalis will host a conference call to discuss the announcement and updated business outlook before market open on Monday, September 20, 2021 at 6:00 a.m. Pacific Time / 9:00 a.m. Eastern Time. The conference call can be accessed live over the phone by dialing (866) 220-8061 for U.S. callers or (470) 495-9168 for international callers, using the conference ID: 8835748. The live webinar can be accessed at https://investors.personalis.com.

    About the VA Million Veteran Program

    Launched in 2011, the VA MVP is a landmark research effort aimed at better understanding how genetic variations affect health. Up to two-million veterans are expected to enroll in the VA MVP. Data and genetic samples collected through the program are stored securely and made available for studies by authorized researchers, with stringent safeguards in place to protect Veterans' private health information. The VA MVP was enrolling veterans at 63 VA medical centers nationwide prior to the pandemic. The VA's central biorepository is equipped with a state-of-the-art robotic system for DNA extraction and storage and is currently being expanded to support up to 4 million samples. With approximately 840,000 enrollees since 2011, the VA MVP already far exceeds the enrollment numbers of any single VA study or research program in the past, and is in fact one of the largest research cohorts of its kind in the world. The VA MVP provides researchers with a rich resource of genetic, health, lifestyle, and military-exposure data collected from questionnaires, medical records, and genetic analyses. By combining this information into a single database, the VA MVP promises to advance knowledge about the complex links between genes and health. Veterans' privacy and confidentiality are top priorities in the VA MVP, as in all VA research. For more information about the VA MVP, visit www.research.va.gov/MVP. This press release does not imply a Department of Veterans Affairs endorsement, and is neither paid for nor sponsored, in whole or in part, by any element of the United States government.

    About Personalis, Inc.

    Personalis, Inc. is a leader in advanced cancer genomics for enabling the next generation of precision cancer therapies and diagnostics. The Personalis NeXT PlatformTM is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers and clinicians with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. In population sequencing, Personalis operates one of the largest sequencing laboratories globally and is currently the sole sequencing provider to the VA MVP. To enable cancer and population sequencing, the Personalis Clinical Laboratory is built with a focus on clinical accuracy, quality, big data, scale, and efficiency. The laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from the results predicted, and reported results should not be considered an indication of future performance. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as "estimate," "expect," "outlook," "should," "target," "will," or "would" or similar expressions and the negatives of those terms. These statements include, but are not limited to, statements regarding the company's expectations for revenue and net loss for the third quarter and full year of 2021 and growth in 2022 revenue from biopharma and all other customers, excluding VA MVP. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the company's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks, uncertainties and other factors relate to, among others: the timing and pace of new orders from customers; the extent to which the company may realize revenue from its VA MVP contract and task orders thereunder and the continued receipt of VA MVP samples; the launch of new products and new product features, such as NeXT Personal; the market adoption of offerings launched in 2020, such as Personalis' whole exome liquid biopsy product; the timing of tissue, blood, and other specimen sample receipts from customers (including from the VA MVP), which can materially impact revenue quarter over quarter and year over year; whether orders for the NeXT Platform and revenue from biopharmaceutical and other customers increase in future periods; the success of Personalis' collaborations; the success of the company's international expansion plans; the evolution of cancer therapies and market adoption of the company's services; and the ongoing COVID-19 pandemic, which may significantly impact the company's business and operations and the business and operations of the company's customers and suppliers. These and other potential risks and uncertainties that could cause actual results to differ from the results predicted are further described under the captions "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the company's Quarterly Report on Form 10-Q for the period ended June 30, 2021, and the company's Annual Report on Form 10-K filed on February 25, 2021. All information provided in this release is as of the date of this press release, and any forward-looking statements contained herein are based on assumptions that the company believes to be reasonable as of this date. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to the company on the date hereof. Personalis undertakes no duty to update this information unless required by law.

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  2. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, announced today that its management team will participate at the Morgan Stanley 19th Annual Global Healthcare Conference on Thursday, September 9, 2021 at 3:30 p.m. Eastern Time.

    About Personalis, Inc.

    Personalis, Inc. is a leader in advanced cancer genomics for enabling the next generation of precision cancer therapies and diagnostics. The Personalis NeXT PlatformTM is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers and clinicians with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. In population sequencing, Personalis operates…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, announced today that its management team will participate at the Morgan Stanley 19th Annual Global Healthcare Conference on Thursday, September 9, 2021 at 3:30 p.m. Eastern Time.

    About Personalis, Inc.

    Personalis, Inc. is a leader in advanced cancer genomics for enabling the next generation of precision cancer therapies and diagnostics. The Personalis NeXT PlatformTM is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers and clinicians with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. In population sequencing, Personalis operates one of the largest sequencing laboratories globally and is currently the sole sequencing provider to the VA MVP. To enable cancer and population sequencing, The Personalis Clinical Laboratory is built with a focus on clinical accuracy, quality, big data, scale, and efficiency. The laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).

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  3. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, today announced that the company will relocate both its corporate headquarters and the Personalis Clinical Laboratory from Menlo Park to 6600 Dumbarton Circle in Fremont. The new facility will support the Company's future growth plans and provide greater capacity for laboratory operations and research & development activities. The relocation of the Company's corporate headquarters to this new facility is expected to occur within the next 12 months.

    "Our new headquarters is expected to enable Personalis to continue our growth as we look to further expand our product offerings and strengthen our position in the cancer diagnostics market," said John West, Chief Executive…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, today announced that the company will relocate both its corporate headquarters and the Personalis Clinical Laboratory from Menlo Park to 6600 Dumbarton Circle in Fremont. The new facility will support the Company's future growth plans and provide greater capacity for laboratory operations and research & development activities. The relocation of the Company's corporate headquarters to this new facility is expected to occur within the next 12 months.

    "Our new headquarters is expected to enable Personalis to continue our growth as we look to further expand our product offerings and strengthen our position in the cancer diagnostics market," said John West, Chief Executive Officer. "As we've experienced so far, the San Francisco Bay Area has a deep pool of talent and we plan to continue to recruit top scientific, clinical and commercial professionals with the skill sets necessary to achieve our business goals and support our many initiatives."

    Personalis has signed a 13-year lease for the 100,000 square foot facility which is approximately double the amount of space of its current Menlo Park location. The new facility is intended to allow for expansion of the Company's CLIA-certified and CAP-accredited laboratory for clinical testing to support biopharma customers and clinical diagnostic testing. In addition, the new space is intended to support the expansion of R&D efforts to bring leading edge products and services to the marketplace.

    About Personalis, Inc.

    Personalis, Inc. is a leader in advanced cancer genomics for enabling the next generation of precision cancer therapies and diagnostics. The Personalis NeXT Platform™ is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers and clinicians with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. In population sequencing, Personalis operates one of the largest sequencing laboratories globally and is currently the sole sequencing provider to the VA MVP. To enable cancer and population sequencing, the Personalis Clinical Laboratory is built with a focus on clinical accuracy, quality, big data, scale, and efficiency. The laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).

    Forward-Looking Statements

    All statements in this press release that are not historical are "forward-looking statements" within the meaning of U.S. securities laws, including statements relating to the expected benefits or timing of relocating the Company's corporate headquarters and the Personalis Clinical Laboratory, attributes or advantages of the Personalis NeXT Platform, Personalis' business opportunities, leadership, plans, products, services, clinical testing, vision, growth, or expansion, or other future events. Such forward-looking statements involve risks and uncertainties, including those related to the COVID-19 pandemic, that could cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements. Factors that could materially affect actual results can be found in Personalis' filings with the U.S. Securities and Exchange Commission, including Personalis' most recent reports on Forms 8-K, 10-K and 10-Q, and include those listed under the caption "Risk Factors." Personalis disclaims any obligation to update such forward-looking statements.

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  4. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer and population sequencing, today reported financial results for the second quarter ended June 30, 2021.

    Second Quarter and Recent Highlights

    • Record quarterly revenue of $21.7 million in the second quarter of 2021 compared with $19.5 million in the second quarter of 2020, an 11% increase
    • Revenue of $8.2 million from biopharma and all other customers, excluding the U.S. Department of Veterans Affairs Million Veteran Program (VA MVP), in the second quarter of 2021 compared with $4.7 million in the second quarter of 2020, a 72% increase
    • Ended the second quarter with cash, cash equivalents, and short-term investments of $328.9 million as of June 30, 2021
    • Achieved milestone…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer and population sequencing, today reported financial results for the second quarter ended June 30, 2021.

    Second Quarter and Recent Highlights

    • Record quarterly revenue of $21.7 million in the second quarter of 2021 compared with $19.5 million in the second quarter of 2020, an 11% increase
    • Revenue of $8.2 million from biopharma and all other customers, excluding the U.S. Department of Veterans Affairs Million Veteran Program (VA MVP), in the second quarter of 2021 compared with $4.7 million in the second quarter of 2020, a 72% increase
    • Ended the second quarter with cash, cash equivalents, and short-term investments of $328.9 million as of June 30, 2021
    • Achieved milestone of delivering more than 125,000 whole human genome sequences to the VA MVP

    "I'm proud to say that we were able to report record revenue once again this quarter and that we achieved our twentieth consecutive quarter of growth, as we converted an increasing number of orders into revenue. Revenue from biopharma and all other customers grew 72% over the same period of the prior year, and increased sequentially for the seventh consecutive quarter," said John West, Chief Executive Officer. "Recently, we achieved a significant milestone of sequencing our 125,000th whole human genome for the VA MVP, which highlights our expertise and ability to scale. In addition, our development efforts for NeXT Personal, our Minimal Residual Disease (MRD) offering that we expect to launch in 2021, remain on-track."

    Second Quarter 2021 Financial Results

    Revenue was $21.7 million in the three months ended June 30, 2021, up 11% from $19.5 million in the same period of the prior year.

    Gross margin was 37.7% in the three months ended June 30, 2021, compared with 24.0% in the same period of the prior year.

    Operating expenses were $23.1 million in the three months ended June 30, 2021, compared with $14.2 million in the same period of the prior year.

    Net loss was $15.0 million in the three months ended June 30, 2021 and net loss per share was $0.34 based on a weighted-average basic and diluted share count of 44.0 million, compared with a net loss of $9.3 million and a net loss per share of $0.29 on a weighted-average basic and diluted share count of 31.7 million in the same period of the prior year.

    Business Outlook

    Personalis expects the following for the third quarter of 2021:

    • Total revenue to be approximately $22.2 million
    • Revenue from biopharma and all other customers, excluding VA MVP, to be in the range of $7.5 million to $8.5 million
    • Net Loss to be in the range of $17 million to $18 million; estimated outstanding shares of 44 million

    Personalis expects the following for the full year of 2021:

    • Total revenue to be approximately $85 million
    • Revenue from biopharma and all other customers, excluding VA MVP, to be in the range of $33 million to $34 million
    • Net Loss to be in the range of $65 million to $70 million; estimated outstanding shares of 44 million

    Webcast and Conference Call Information

    Personalis will host a conference call to discuss the second quarter 2021 financial results after market close on Wednesday, August 4, 2021 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live over the phone by dialing (866) 220-8061 for U.S. callers or (470) 495-9168 for international callers, using the conference ID: 8564509. The live webinar can be accessed at https://investors.personalis.com.

    About Personalis, Inc.

    Personalis, Inc. is a leader in advanced cancer genomics for enabling the next generation of precision cancer therapies and diagnostics. The Personalis NeXT PlatformTM is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers and clinicians with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. In population sequencing, Personalis operates one of the largest sequencing laboratories globally and is currently the sole sequencing provider to the VA MVP. To enable cancer and population sequencing, the Personalis Clinical Laboratory is built with a focus on clinical accuracy, quality, big data, scale, and efficiency. The laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from the results predicted, and reported results should not be considered an indication of future performance. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as "estimate," "expect," "should," "target," "will," or "would" or similar expressions and the negatives of those terms. These statements include, but are not limited to, statements regarding the company's expectations for revenue and net loss for the third quarter and full year of 2021. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks, uncertainties and other factors relate to, among others: the timing and pace of new orders from customers, including from the U.S. Department of Veterans Affairs Million Veteran Program, which was the company's largest customer in 2018, 2019, and 2020; the launch of new products and new product features, such as NeXT Personal; the market adoption of offerings launched in 2020, such as Personalis' whole exome liquid biopsy product; the timing of tissue, blood, and other specimen sample receipts from customers, which can materially impact revenue quarter over quarter and year over year; whether orders for the NeXT Platform and revenue from biopharmaceutical customers increase in future periods; the success of Personalis' collaborations; the success of the company's international expansion plans; the evolution of cancer therapies and market adoption of the company's services; the company's expectations regarding future performance; and the ongoing COVID-19 pandemic, which may significantly impact the company's business and operations and the business and operations of our customers and suppliers. In addition, other potential risks and uncertainties that could cause actual results to differ from the results predicted include, among others, those risks and uncertainties included under the captions "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Quarterly Report on Form 10-Q for the period ended June 30, 2021 that will be filed after this earnings release, and risk factors included within the Annual Report on Form 10-K filed on February 25, 2021. All information provided in this release is as of the date of this press release, and any forward-looking statements contained herein are based on assumptions that we believe to be reasonable as of this date. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. Personalis undertakes no duty to update this information unless required by law.

    PERSONALIS, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)

    (in thousands, except share and per share data)

     

     

     

    Three Months Ended June 30,

     

     

    Six Months Ended June 30,

     

     

     

    2021

     

     

    2020

     

     

    2021

     

     

    2020

     

    Revenue

     

    $

    21,670

     

     

    $

    19,495

     

     

    $

    42,551

     

     

    $

    38,656

     

    Costs and expenses

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Cost of revenue

     

     

    13,502

     

     

     

    14,823

     

     

     

    26,956

     

     

     

    29,945

     

    Research and development

     

     

    11,687

     

     

     

    6,465

     

     

     

    21,183

     

     

     

    12,855

     

    Selling, general and administrative

     

     

    11,428

     

     

     

    7,705

     

     

     

    21,849

     

     

     

    14,979

     

    Total costs and expenses

     

     

    36,617

     

     

     

    28,993

     

     

     

    69,988

     

     

     

    57,779

     

    Loss from operations

     

     

    (14,947

    )

     

     

    (9,498

    )

     

     

    (27,437

    )

     

     

    (19,123

    )

    Interest income

     

     

    103

     

     

     

    246

     

     

     

    198

     

     

     

    756

     

    Interest expense

     

     

    (65

    )

     

     

     

     

     

    (65

    )

     

     

    (2

    )

    Other income (expense), net

     

     

    (36

    )

     

     

    1

     

     

     

    (48

    )

     

     

    9

     

    Loss before income taxes

     

     

    (14,945

    )

     

     

    (9,251

    )

     

     

    (27,352

    )

     

     

    (18,360

    )

    Provision for income taxes

     

     

    8

     

     

     

    4

     

     

     

    5

     

     

     

    34

     

    Net loss

     

    $

    (14,953

    )

     

    $

    (9,255

    )

     

    $

    (27,357

    )

     

    $

    (18,394

    )

    Net loss per share, basic and diluted

     

    $

    (0.34

    )

     

    $

    (0.29

    )

     

    $

    (0.63

    )

     

    $

    (0.58

    )

    Weighted-average shares outstanding, basic and diluted

     

     

    43,960,794

     

     

     

    31,731,628

     

     

     

    43,113,195

     

     

     

    31,538,329

     

    PERSONALIS, INC.

    SUPPLEMENTAL REVENUE INFORMATION (unaudited)

    (in thousands)

     

     

     

    Three Months Ended June 30,

     

    Six Months Ended June 30,

     

     

    2021

     

    2020

     

    2021

     

    2020

    VA MVP

     

    $

    13,507

     

    $

    14,750

     

    $

    26,717

     

    $

    29,506

    All other customers

     

     

    8,163

     

     

    4,745

     

     

    15,834

     

     

    9,150

    Total revenue

     

    $

    21,670

     

    $

    19,495

     

    $

    42,551

     

    $

    38,656

    PERSONALIS, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited)

    (in thousands, except share and per share data)

     

     

     

    June 30, 2021

     

    December 31, 2020

    Assets

     

     

     

     

     

     

     

     

    Current assets

     

     

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    70,080

     

     

    $

    68,525

     

    Short-term investments

     

     

    258,827

     

     

     

    134,765

     

    Accounts receivable, net

     

     

    9,278

     

     

     

    6,349

     

    Inventory and other deferred costs

     

     

    7,321

     

     

     

    5,639

     

    Prepaid expenses and other current assets

     

     

    8,803

     

     

     

    5,441

     

    Total current assets

     

     

    354,309

     

     

     

    220,719

     

    Property and equipment, net

     

     

    14,258

     

     

     

    11,834

     

    Operating lease right-of-use assets

     

     

    11,126

     

     

     

    10,271

     

    Other long-term assets

     

     

    3,647

     

     

     

    2,018

     

    Total assets

     

    $

    383,340

     

     

    $

    244,842

     

    Liabilities and Stockholders' Equity

     

     

     

     

     

     

     

     

    Current liabilities

     

     

     

     

     

     

     

     

    Accounts payable

     

    $

    8,919

     

     

    $

    8,301

     

    Accrued and other current liabilities

     

     

    13,708

     

     

     

    11,301

     

    Contract liabilities

     

     

    11,460

     

     

     

    21,034

     

    Total current liabilities

     

     

    34,087

     

     

     

    40,636

     

    Long-term operating lease liabilities

     

     

    8,518

     

     

     

    8,541

     

    Other long-term liabilities

     

     

    1,988

     

     

     

    720

     

    Total liabilities

     

     

    44,593

     

     

     

    49,897

     

    Commitments and Contingencies

     

     

     

     

     

     

     

     

    Stockholders' equity

     

     

     

     

     

     

     

     

    Preferred stock, $0.0001 par value — 10,000,000 shares authorized; none issued

     

     

     

     

     

     

    Common stock, $0.0001 par value — 200,000,000 shares authorized; 44,209,968 and 39,105,548 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively

     

     

    4

     

     

     

    4

     

    Additional paid-in capital

     

     

    547,951

     

     

     

    376,788

     

    Accumulated other comprehensive income (loss)

     

     

    18

     

     

     

    22

     

    Accumulated deficit

     

     

    (209,226

    )

     

     

    (181,869

    )

    Total stockholders' equity

     

     

    338,747

     

     

     

    194,945

     

    Total liabilities and stockholders' equity

     

    $

    383,340

     

     

    $

    244,842

     

     

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  5. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, announced today that its management team will participate at the 6th Annual Needham Virtual MedTech & Diagnostics 1x1 Conference on Tuesday, August 17, 2021.

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to the VA MVP. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform® is designed…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, announced today that its management team will participate at the 6th Annual Needham Virtual MedTech & Diagnostics 1x1 Conference on Tuesday, August 17, 2021.

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to the VA MVP. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing Personalis' biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. Personalis' Clinical Laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).

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  6. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced translational genomics and diagnostics for cancer, today announced the publication of its study "Prediction of immunotherapy response in melanoma through combined modeling of neoantigen burden and immune-related resistance mechanisms,"(1) in Clinical Cancer Research, a journal published by the American Association for Cancer Research.

    The study details the development of the Personalis Neoantigen Presentation Score (NEOPS™), a novel composite biomarker for predicting response to cancer immunotherapy. Enabled by comprehensive tumor immunogenomic profiling from the Personalis NeXT Platform, NEOPS simultaneously models both neoantigen burden and immune-related resistance mechanisms to better…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced translational genomics and diagnostics for cancer, today announced the publication of its study "Prediction of immunotherapy response in melanoma through combined modeling of neoantigen burden and immune-related resistance mechanisms,"(1) in Clinical Cancer Research, a journal published by the American Association for Cancer Research.

    The study details the development of the Personalis Neoantigen Presentation Score (NEOPS™), a novel composite biomarker for predicting response to cancer immunotherapy. Enabled by comprehensive tumor immunogenomic profiling from the Personalis NeXT Platform, NEOPS simultaneously models both neoantigen burden and immune-related resistance mechanisms to better predict immunotherapy response in a cohort of late-stage melanoma patients. In this study, NEOPS was more strongly predictive of therapy response than other standard single analyte and investigational biomarkers tested, including tumor mutational burden. Performance of this composite biomarker was initially tested on a cohort of late-stage melanoma patients receiving immune checkpoint blockade therapies and later validated on an independent dataset of similarly treated late-stage melanoma patients.

    "Given the varied response to immunotherapy as well as the potential toxicities associated with treatment, there is a need for improved biomarker approaches to better predict which patients will respond to therapy," said Richard Chen, MD, Personalis CMO. "Our findings suggest that integrative, multi-omic biomarkers like NEOPS can be stronger predictors of response than simpler, single-analyte approaches, especially in the setting of new cancer therapies where the underlying biological mechanisms governing response are highly complex. We feel that NEOPS and other composite biomarkers will be important, sharper tools for enabling precision oncology."

    NEOPS utilizes technology that Personalis has been developing since 2015 to better predict neoantigens and identify associated escape mechanisms such as HLA LOH. Our ImmunoID NeXT, and clinical NeXT Dx tests make this advanced capability, including NEOPS, available to pharmaceutical researchers and clinicians for clinical trials and investigational use, and additional clinical studies with other tumor types are planned.

    About Personalis, Inc.

    Personalis, Inc. is a leader in advanced cancer genomics for enabling the next generation of precision cancer therapies and diagnostics. The Personalis NeXT Platform™ is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers and clinicians with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. In population sequencing, Personalis operates one of the largest sequencing laboratories globally and is currently the sole sequencing provider to the VA MVP. To enable cancer and population sequencing, The Personalis Clinical Laboratory is built with a focus on clinical accuracy, quality, big data, scale, and efficiency. The laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).

    Forward-Looking Statements

    All statements in this press release that are not historical are "forward-looking statements" within the meaning of U.S. securities laws, including statements relating to attributes or advantages of NEOPS or the Personalis NeXT Platform, Personalis' business opportunities, leadership, plans, vision or growth, or other future events. Such forward-looking statements involve risks and uncertainties, including those related to the COVID-19 pandemic, that could cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements. Factors that could materially affect actual results can be found in Personalis' filings with the U.S. Securities and Exchange Commission, including Personalis' most recent reports on Forms 8-K, 10-K and 10-Q, and include those listed under the caption "Risk Factors." Personalis disclaims any obligation to update such forward-looking statements.

    (1) Clin Cancer Res August 1 2021 (27) (15) 4265-4276; DOI: 10.1158/1078-0432.CCR-20-4314

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  7. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, announced today it will release its second quarter 2021 financial results after the market closes on Wednesday, August 4, 2021. In conjunction with the release, the Company will host a conference call and webcast that day at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss its financial results and recent highlights.

    Interested parties may access the live call via telephone by dialing (866) 220-8061 for domestic callers or (470) 495-9168 for international callers, using conference ID: 8564509. The live webinar of the call may be accessed by visiting the Events section of the company's website at investors.personalis.com. A replay of the webinar will be available…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, announced today it will release its second quarter 2021 financial results after the market closes on Wednesday, August 4, 2021. In conjunction with the release, the Company will host a conference call and webcast that day at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss its financial results and recent highlights.

    Interested parties may access the live call via telephone by dialing (866) 220-8061 for domestic callers or (470) 495-9168 for international callers, using conference ID: 8564509. The live webinar of the call may be accessed by visiting the Events section of the company's website at investors.personalis.com. A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company's website.

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency, and quality. Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to the VA MVP. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue and matched blood sample. The Personalis Clinical Laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).

    Forward-Looking Statements

    All statements in this press release that are not historical are "forward-looking statements" within the meaning of U.S. securities laws, including statements relating to attributes or advantages of the Personalis NeXT Platform, Personalis' business opportunities, leadership, plans, vision or growth, or other future events. Such forward-looking statements involve risks and uncertainties, including those related to the COVID-19 pandemic, that could cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements. Factors that could materially affect actual results can be found in Personalis' filings with the U.S. Securities and Exchange Commission, including Personalis' most recent reports on Forms 8-K, 10-K and 10-Q, and include those listed under the caption "Risk Factors." Personalis disclaims any obligation to update such forward-looking statements.

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  8. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, today announced its inaugural event, NeXT Level Biomarkers Symposium, which will showcase novel research into emerging biomarkers using the Personalis NeXT Platform™.

    This event will detail the latest research from Personalis as well as a case study done in collaboration with the Parker Institute for Cancer Immunotherapy. Presentations from Personalis will focus on recently published research into HLA loss of heterozygosity, neoantigen prediction, as well as Personalis' novel composite biomarker, the Neoantigen Presentation Score (NEOPS™). In addition, Dr. Theresa LaVallee will be presenting findings from the PRINCE trial based on data developed and analyzed in collaboration…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, today announced its inaugural event, NeXT Level Biomarkers Symposium, which will showcase novel research into emerging biomarkers using the Personalis NeXT Platform™.

    This event will detail the latest research from Personalis as well as a case study done in collaboration with the Parker Institute for Cancer Immunotherapy. Presentations from Personalis will focus on recently published research into HLA loss of heterozygosity, neoantigen prediction, as well as Personalis' novel composite biomarker, the Neoantigen Presentation Score (NEOPS™). In addition, Dr. Theresa LaVallee will be presenting findings from the PRINCE trial based on data developed and analyzed in collaboration with Personalis.

    The agenda for NeXT Level Biomarkers Symposium will cover:

    • Biomarker Discovery with ImmunoID NeXT Platform®
    • Exploring HLA LOH with the DASH (Deletion of Allele-Specific HLAs) Algorithm
    • Neoantigen Binding Prediction and Biomarker Discovery with SHERPA™
    • Composite Biomarkers and our Neoantigen Presentation Score (NEOPS™)
    • Parker Institute Case Study: The PRINCE Trial
    • NeXT Liquid Biopsy™ Overview and Review of AACR Data
    • NeXT Dx™ and Companion Diagnostics (CDx) with Personalis

    "We are excited to share our latest technology and product advances with our partners," said Richard Chen, MD, Personalis CSO. "Given the complex biology underlying cancer progression and response to treatment, our mission at Personalis is to provide broader, more comprehensive molecular profiling and testing for each patient's cancer, thereby giving biopharma, physicians, and patients the information they need for precision oncology now and with an eye to the future. These new technologies help further that mission."

    Further information, including registration information, on the NeXT Level Biomarkers Symposium can be found at this link.

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency, and quality. Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to the VA MVP. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. The Personalis Clinical Laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).

    Forward-Looking Statements

    All statements in this press release that are not historical are "forward-looking statements" within the meaning of U.S. securities laws, including statements relating to attributes or advantages of the Personalis NeXT Platform, Personalis' business opportunities, leadership, plans, vision or growth, or other future events. Such forward-looking statements involve risks and uncertainties, including those related to the COVID-19 pandemic, that could cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements. Factors that could materially affect actual results can be found in Personalis' filings with the U.S. Securities and Exchange Commission, including Personalis' most recent reports on Forms 8-K, 10-K and 10-Q, and include those listed under the caption "Risk Factors." Personalis disclaims any obligation to update such forward-looking statements.

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  9. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for population sequencing and cancer, announced today that it has delivered the 125,000th whole human genome sequence dataset to the U.S. Department of Veterans Affairs Million Veteran Program (VA MVP).

    First contracted by the VA MVP in 2012, Personalis has delivered over 50,000 of these genomes in the past twelve months.

    "This represents another important landmark for both the program and for Personalis," said John West, Chief Executive Officer. "We congratulate the VA MVP for reaching this important milestone. We strongly believe that the research projects being performed today will enable precision medicine in healthcare systems in the future across a wide range of disease areas…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for population sequencing and cancer, announced today that it has delivered the 125,000th whole human genome sequence dataset to the U.S. Department of Veterans Affairs Million Veteran Program (VA MVP).

    First contracted by the VA MVP in 2012, Personalis has delivered over 50,000 of these genomes in the past twelve months.

    "This represents another important landmark for both the program and for Personalis," said John West, Chief Executive Officer. "We congratulate the VA MVP for reaching this important milestone. We strongly believe that the research projects being performed today will enable precision medicine in healthcare systems in the future across a wide range of disease areas. As a global leader in genomic sequencing and comprehensive analytics services, Personalis is uniquely suited to lead these population-scale efforts and we are currently in the process of expanding our business operations internationally."

    About the VA Million Veteran Program

    Launched in 2011, the VA MVP is a landmark research effort aimed at better understanding how genetic variations affect health. Up to two-million veterans are expected to enroll in the VA MVP. Data and genetic samples collected through the program are stored securely and made available for studies by authorized researchers, with stringent safeguards in place to protect Veterans' private health information. The VA MVP was enrolling veterans at 63 VA medical centers nationwide prior to the pandemic. The VA's central biorepository is equipped with a state-of-the-art robotic system for DNA extraction and storage and is currently being expanded to support up to 4 million samples. With approximately 830,000 enrollees since 2011, the VA MVP already far exceeds the enrollment numbers of any single VA study or research program in the past, and is in fact one of the largest research cohorts of its kind in the world. The VA MVP provides researchers with a rich resource of genetic, health, lifestyle, and military-exposure data collected from questionnaires, medical records, and genetic analyses. By combining this information into a single database, the VA MVP promises to advance knowledge about the complex links between genes and health. Veterans' privacy and confidentiality are top priorities in the VA MVP, as in all VA research. For more information about the VA MVP, visit www.research.va.gov/MVP. This press release does not imply a Department of Veterans Affairs endorsement, and is neither paid for nor sponsored, in whole or in part, by any element of the United States government.

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to the VA MVP. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform®is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. The Personalis Clinical Laboratory is GxP-aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).

    Forward-Looking Statements

    All statements in this press release that are not historical are "forward-looking statements" within the meaning of U.S. securities laws, including statements relating to attributes or advantages of the Personalis NeXT Platform, Personalis' services for the VA MVP (including continued receipt of VA MVP samples and continued laboratory operations at the company), the company's business opportunities, leadership, plans, vision, growth or expansion, or other future events. Such forward-looking statements involve risks and uncertainties, including those related to the COVID-19 pandemic, that could cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements. Factors that could materially affect actual results can be found in Personalis' filings with the U.S. Securities and Exchange Commission, including the company's most recent reports on Forms 8-K, 10-K and 10-Q, and include those listed under the caption "Risk Factors." Personalis disclaims any obligation to update such forward-looking statements.

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  10. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, announced today that its management team will participate at the Oppenheimer MedTech, Tools & Diagnostics Summit on Wednesday, May 26, 2021.

    Interested parties may access the pre-recorded and archived webcast of the presentation for 90 days following the conference through the "Events" section of Personalis' website at http://investors.personalis.com.

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing programs globally and is currently the sole sequencing provider to the U.S. Department of Veterans Affairs Million Veterans…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, announced today that its management team will participate at the Oppenheimer MedTech, Tools & Diagnostics Summit on Wednesday, May 26, 2021.

    Interested parties may access the pre-recorded and archived webcast of the presentation for 90 days following the conference through the "Events" section of Personalis' website at http://investors.personalis.com.

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing programs globally and is currently the sole sequencing provider to the U.S. Department of Veterans Affairs Million Veterans Program. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue or blood sample. The Personalis® Clinical Laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited.

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  11. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, today announced that the company will present at Biomarkers Week Online 2021.

    The presentation, titled "ImmunoID NeXT Platform® for comprehensive tumor immunogenomics and advanced biomarker discovery," will describe the Personalis universal cancer immunogenomics platform, ImmunoID NeXT™. Erin Newburn, MS, PhD, will present for Personalis. Dr. Newburn will provide an overview of the platform, which combines highly sensitive, exome-scale DNA and RNA sequencing with advanced analytics to provide a multidimensional view of the tumor and the tumor microenvironment (TME) from a single sample preparation. Dr. Newburn will review a case study in a cohort of 51 late-stage melanoma…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, today announced that the company will present at Biomarkers Week Online 2021.

    The presentation, titled "ImmunoID NeXT Platform® for comprehensive tumor immunogenomics and advanced biomarker discovery," will describe the Personalis universal cancer immunogenomics platform, ImmunoID NeXT™. Erin Newburn, MS, PhD, will present for Personalis. Dr. Newburn will provide an overview of the platform, which combines highly sensitive, exome-scale DNA and RNA sequencing with advanced analytics to provide a multidimensional view of the tumor and the tumor microenvironment (TME) from a single sample preparation. Dr. Newburn will review a case study in a cohort of 51 late-stage melanoma patients that demonstrates how the integration of neoantigen burden, HLA LOH, and Antigen Presentation Machinery (APM) mutational data formed a composite biomarker that more accurately predicted response to checkpoint blockade than other markers. Additionally, Dr. Newburn will highlight our NeXT Liquid Biopsy™, an exome-wide liquid biopsy approach combined with ImmunoID NeXT, to further explore critical areas of tumor biology.

    ImmunoID NeXT is the first platform to enable comprehensive analysis of both a tumor and its immune microenvironment from a single sample. The ImmunoID NeXT Platform can be used to investigate the key tumor- and immune-related areas of cancer biology, consolidating multiple oncology biomarker assays into one and maximizing the biological information that can be generated from a precious tumor specimen.

    Personalis is a co-sponsor of Biomarkers Week and will have representatives available to answer questions about the company's cancer immunogenomics capabilities.

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency, and quality. Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to the VA MVP. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue and matched blood sample. The Personalis Clinical Laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).

    Forward-Looking Statements

    All statements in this press release that are not historical are "forward-looking statements" within the meaning of U.S. securities laws, including statements relating to attributes or advantages of the Personalis NeXT Platform, Personalis' business opportunities, leadership, plans, vision or growth, or other future events. Such forward-looking statements involve risks and uncertainties, including those related to the COVID-19 pandemic, that could cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements. Factors that could materially affect actual results can be found in Personalis' filings with the U.S. Securities and Exchange Commission, including Personalis' most recent reports on Forms 8-K, 10-K and 10-Q, and include those listed under the caption "Risk Factors." Personalis disclaims any obligation to update such forward-looking statements.

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  12. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for population sequencing and cancer, today reported financial results for the first quarter ended March 31, 2021.

    First Quarter Highlights

    • Record quarterly revenue of $20.9 million in the first quarter of 2021 compared with $19.2 million in the first quarter of 2020, a 9% increase
    • Revenue of $7.7 million from biopharma and all other customers, excluding VA MVP, in the first quarter of 2021 compared with $4.4 million in the first quarter of 2020, a 74% increase
    • Announced a collaboration with Natera in the field of personalized oncology; Personalis to provide the exome sequence data for Natera to pair with their personalized ctDNA platform, SignateraTM
    • Announced a collaboration…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for population sequencing and cancer, today reported financial results for the first quarter ended March 31, 2021.

    First Quarter Highlights

    • Record quarterly revenue of $20.9 million in the first quarter of 2021 compared with $19.2 million in the first quarter of 2020, a 9% increase
    • Revenue of $7.7 million from biopharma and all other customers, excluding VA MVP, in the first quarter of 2021 compared with $4.4 million in the first quarter of 2020, a 74% increase
    • Announced a collaboration with Natera in the field of personalized oncology; Personalis to provide the exome sequence data for Natera to pair with their personalized ctDNA platform, SignateraTM
    • Announced a collaboration with MapKure, LLC, a company jointly owned by BeiGene, Ltd. and SpringWorks Therapeutics, Inc., LLC for use of the NeXT PlatformTM for clinical trials and companion diagnostic development
    • Added approximately $162 million of cash to balance sheet from public offering of common stock financing in the first quarter of 2021; ended the quarter with cash, cash equivalents, and short-term investments of $353.4 million as of March 31, 2021

    "I'm proud to say that we were able to report record revenue once again this quarter and achieved our nineteenth consecutive quarter of growth, as we converted an increasing number of orders into revenue. Biopharma and all other customer revenue grew 74% year-over-year, and orders from customers exceeded revenues reported once again this quarter," said John West, Chief Executive Officer. "Recently, we announced a partnership with Natera in the field of personalized oncology, and a companion diagnostics collaboration with MapKure. Both collaborations further validate our NeXT platform as a leading front end tissue-sequencing platform, capable of detecting cancer cell mutations that conventional exome tests often miss. Our tissue offering complements our whole exome liquid biopsy product that we launched in August 2020 and NeXT Personal, our Minimal Residual Disease (MRD) offering that we expect to launch in 2021, providing Personalis with access to three distinct revenue opportunities in the rapidly growing cancer monitoring market."

    First Quarter 2021 Financial Results

    Revenues were $20.9 million in the three months ended March 31, 2021, up 9% from $19.2 million in the same period of the prior year.

    Gross margin was 35.6% in the three months ended March 31, 2021, compared with 21.1% in the same period of the prior year.

    Operating expenses were $19.9 million in the three months ended March 31, 2021, compared with $13.7 million in the same period of the prior year.

    Net loss was $12.4 million in the three months ended March 31, 2021 and net loss per share was $0.29 based on a weighted-average basic and diluted share count of 42.3 million, compared with a net loss of $9.1 million and a net loss per share of $0.29 on a weighted-average basic and diluted share count of 31.3 million in the same period of the prior year.

    Business Outlook

    Personalis expects the following for the second quarter of 2021:

    • Total Company revenues to be approximately $21.3 million
    • Revenues from biopharma and all other customers, excluding VA MVP, to be in the range of $7.3 million to $7.7 million
    • Net Loss to be in the range of $16 million to $17 million; estimated outstanding shares of 43 million

    Personalis expects the following for the full year of 2021:

    • Total Company revenues to be approximately $85 million
    • Revenues from biopharma and all other customers, excluding VA MVP, to be in the range of $30 million to $32 million
    • Net Loss to be in the range of $70 million to $75 million; estimated outstanding shares of 44 million

    Webcast and Conference Call Information

    Personalis will host a conference call to discuss the first quarter 2021 financial results after market close on Wednesday, May 5, 2021 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live over the phone by dialing (866) 220-8061 for U.S. callers or (470) 495-9168 for international callers, using the conference ID: 6587766. The live webinar can be accessed at https://investors.personalis.com.

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to the VA MVP. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue or blood sample. The Personalis Clinical Laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from the results predicted, and reported results should not be considered an indication of future performance. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as "estimate," "expect," "should," "target," "will," or "would" or similar expressions and the negatives of those terms. These statements include, but are not limited to, statements regarding the company's expectations for revenues and net loss for the second quarter and full year of 2021. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks, uncertainties and other factors relate to, among others: the timing and pace of new orders from customers, including from the U.S. Department of Veterans Affairs Million Veteran Program, which was the company's largest customer in 2018, 2019, and 2020; the launch of new products and new product features, such as NeXT Personal; the market adoption of offerings launched in 2020, such as Personalis' whole exome liquid biopsy product; the timing of tissue, blood, and other specimen sample receipts from customers, which can materially impact revenue quarter over quarter and year over year; whether orders for the NeXT Platform and revenues from biopharmaceutical customers increase in future periods; the success of Personalis' collaborations, and including those with Natera and the MapKure; the success of the company's international expansion plans; the evolution of cancer therapies and market adoption of the company's services; the company's expectations regarding future performance; and the ongoing COVID-19 pandemic, which may significantly impact the company's business and operations and the business and operations of our customers and suppliers. In addition, other potential risks and uncertainties that could cause actual results to differ from the results predicted include, among others, those risks and uncertainties included under the captions "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Quarterly Report on Form 10-Q for the period ended March 31, 2021 that will be filed after this earnings release, and risk factors included within the Annual Report on Form 10-K filed on February 25, 2021. All information provided in this release is as of the date of this press release, and any forward-looking statements contained herein are based on assumptions that we believe to be reasonable as of this date. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. Personalis undertakes no duty to update this information unless required by law.

     

    PERSONALIS, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)

    (in thousands, except share and per share data)

     

     

     

     

     

     

    Three Months Ended March 31,

     

     

    2021

     

    2020

    Revenues

     

    $

    20,881

     

     

    $

    19,161

     

    Costs and expenses

     

     

     

     

     

     

     

     

    Costs of revenues

     

     

    13,454

     

     

     

    15,122

     

    Research and development

     

     

    9,496

     

     

     

    6,390

     

    Selling, general and administrative

     

     

    10,421

     

     

     

    7,274

     

    Total costs and expenses

     

     

    33,371

     

     

     

    28,786

     

    Loss from operations

     

     

    (12,490

    )

     

     

    (9,625

    )

    Interest income

     

     

    95

     

     

     

    510

     

    Interest expense

     

     

     

     

     

    (2

    )

    Other income (expense), net

     

     

    (12

    )

     

     

    8

     

    Loss before income taxes

     

     

    (12,407

    )

     

     

    (9,109

    )

    Provision for (benefit from) income taxes

     

     

    (3

    )

     

     

    30

     

    Net loss

     

    $

    (12,404

    )

     

    $

    (9,139

    )

    Net loss per share, basic and diluted

     

    $

    (0.29

    )

     

    $

    (0.29

    )

    Weighted-average shares outstanding, basic and diluted

     

     

    42,265,596

     

     

     

    31,345,029

     

    PERSONALIS, INC.

    SUPPLEMENTAL REVENUE INFORMATION (unaudited)

    (in thousands)

     

     

     

    Three Months Ended March 31,

     

     

     

    2021

     

     

    2020

     

    VA MVP

     

    $

    13,210

     

     

    $

    14,756

     

    All other customers

     

     

    7,671

     

     

     

    4,405

     

    Total

    $

    20,881

     

    $

    19,161

    PERSONALIS, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited)

    (in thousands, except share and per share data)

     

     

     

    March 31,

     

     

    December 31,

     

     

     

    2021

     

     

    2020

     

    Assets

     

     

     

     

     

     

     

     

    Current assets

     

     

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    137,089

     

     

    $

    68,525

     

    Short-term investments

     

     

    216,340

     

     

     

    134,765

     

    Accounts receivable, net

     

     

    8,053

     

     

     

    6,349

     

    Inventory and other deferred costs

     

     

    5,579

     

     

     

    5,639

     

    Prepaid expenses and other current assets

     

     

    5,607

     

     

     

    5,441

     

    Total current assets

     

     

    372,668

     

     

     

    220,719

     

    Property and equipment, net

     

     

    11,152

     

     

     

    11,834

     

    Operating lease right-of-use assets

     

     

    9,899

     

     

     

    10,271

     

    Other long-term assets

     

     

    1,787

     

     

     

    2,018

     

    Total assets

     

    $

    395,506

     

     

    $

    244,842

     

    Liabilities and Stockholders' Equity

     

     

     

     

     

     

     

     

    Current liabilities

     

     

     

     

     

     

     

     

    Accounts payable

     

    $

    6,522

     

     

    $

    8,301

     

    Accrued and other current liabilities

     

     

    13,805

     

     

     

    11,301

     

    Contract liabilities

     

     

    18,237

     

     

     

    21,034

     

    Total current liabilities

     

     

    38,564

     

     

     

    40,636

     

    Long-term operating lease liabilities

     

     

    8,162

     

     

     

    8,541

     

    Other long-term liabilities

     

     

    360

     

     

     

    720

     

    Total liabilities

     

     

    47,086

     

     

     

    49,897

     

    Commitments and Contingencies

     

     

     

     

     

     

     

     

    Stockholders' equity

     

     

     

     

     

     

     

     

    Preferred stock, $0.0001 par value — 10,000,000 shares authorized; none issued

     

     

     

     

     

     

    Common stock, $0.0001 par value — 200,000,000 shares authorized; 43,798,661 and 39,105,548 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively

     

     

    4

     

     

     

    4

     

    Additional paid-in capital

     

     

    542,694

     

     

     

    376,788

     

    Accumulated other comprehensive income (loss)

     

     

    (5

    )

     

     

    22

     

    Accumulated deficit

     

     

    (194,273

    )

     

     

    (181,869

    )

    Total stockholders' equity

     

     

    348,420

     

     

     

    194,945

     

    Total liabilities and stockholders' equity

     

    $

    395,506

     

     

    $

    244,842

     

     

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  13. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, announced today that its management team will present at the 2021 Bank of America Healthcare Conference on Thursday, May 13, 2021 at 5:00 p.m. Eastern Time.

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing programs globally and is currently the sole sequencing provider to the U.S. Department of Veterans Affairs Million Veterans Program. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, announced today that its management team will present at the 2021 Bank of America Healthcare Conference on Thursday, May 13, 2021 at 5:00 p.m. Eastern Time.

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing programs globally and is currently the sole sequencing provider to the U.S. Department of Veterans Affairs Million Veterans Program. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue or blood sample. The Personalis® Clinical Laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited.

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  14. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, announced today it will release its first quarter 2021 financial results after the market closes on Wednesday, May 5, 2021. In conjunction with the release, the Company will host a conference call and webcast that day at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss its financial results and recent highlights.

    Interested parties may access the live call via telephone by dialing (866) 220-8061 for domestic callers or (470) 495-9168 for international callers, using conference ID: 6587766. The live webinar of the call may be accessed by visiting the Events section of the company's website at investors.personalis.com. A replay of the webinar will be available…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, announced today it will release its first quarter 2021 financial results after the market closes on Wednesday, May 5, 2021. In conjunction with the release, the Company will host a conference call and webcast that day at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss its financial results and recent highlights.

    Interested parties may access the live call via telephone by dialing (866) 220-8061 for domestic callers or (470) 495-9168 for international callers, using conference ID: 6587766. The live webinar of the call may be accessed by visiting the Events section of the company's website at investors.personalis.com. A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company's website.

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing programs globally and is currently the sole sequencing provider to the U.S. Department of Veterans Affairs Million Veterans Program. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue or blood sample. The Personalis® Clinical Laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited.

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  15. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, today announced that the company will present new data in scientific posters to be presented at the American Association for Cancer Research (AACR) Annual Meeting 2021, which will be held online, April 10-15, 2021 and May 17-21, 2021.

    These abstracts showcase data from ImmunoID NeXT, the first platform to enable comprehensive analysis of both a tumor and its immune microenvironment from a single sample. The ImmunoID NeXT Platform can be used to investigate the key tumor- and immune-related areas of cancer biology, consolidating multiple oncology biomarker assays into one and maximizing the biological information that can be generated from a precious tumor specimen.

    Following…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, today announced that the company will present new data in scientific posters to be presented at the American Association for Cancer Research (AACR) Annual Meeting 2021, which will be held online, April 10-15, 2021 and May 17-21, 2021.

    These abstracts showcase data from ImmunoID NeXT, the first platform to enable comprehensive analysis of both a tumor and its immune microenvironment from a single sample. The ImmunoID NeXT Platform can be used to investigate the key tumor- and immune-related areas of cancer biology, consolidating multiple oncology biomarker assays into one and maximizing the biological information that can be generated from a precious tumor specimen.

    Following are details and links to the scientific posters that will be presented at the online meeting.

    Poster Number, Session Category and Session Title

     

    Title & Presenter

     

    Date

     

    Location

    399

    Clinical Research (Excluding Trials)

     

    Biomarkers Predictive of Therapeutic Benefit

    Pan-cancer survey of HLA loss of heterozygosity using a robustly validated NGS-based machine learning algorithm

     

    Presenter: Rachel Marty Pyke, PhD

     

    April 10, 2021

    Online

    555

    Clinical Research (Excluding Trials)

     

    Liquid Biopsies: Circulating DNA

    Longitudinal exome-scale liquid biopsy monitoring of evolving therapeutic resistance mechanisms in head and neck squamous cell carcinoma patients receiving anti-PD-1 therapy

     

    Presenter: Charles Abbott, PhD

    April 10, 2021

    Online

    1898

    Immunology

    Tumor

     

    Antigenicity/Processing and Presentation

    Accurate modeling of antigen processing and MHC peptide presentation using large-scale immunopeptidomes and a novel machine learning framework

     

    Presenter: Rachel Marty Pyke, PhD

    April 10, 2021

    Online

    2227

    Molecular and Cellular Biology / Genetics

     

    Genomic Profiling of Tumors

    Pan-cancer shedding patterns of tumor circulating cell free DNA

     

    Presenter: Fábio Navarro, PhD

     

    April 10, 2021

    Online

    2241

    Molecular and Cellular Biology / Genetics

     

    Genomic Profiling of Tumors

    Profiling tumor-infiltrating immune cells using an augmented transcriptome

     

    Presenter: Eric Levy, PhD

    April 10, 2021

    Online

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency, and quality. Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to the VA MVP. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis NeXT Platform is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. The Personalis Clinical Laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).

    Forward-Looking Statements

    All statements in this press release that are not historical are "forward-looking statements" within the meaning of U.S. securities laws, including statements relating to attributes or advantages of the Personalis NeXT Platform, Personalis' business opportunities, leadership, plans, vision or growth, or other future events. Such forward-looking statements involve risks and uncertainties, including those related to the COVID-19 pandemic, that could cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements. Factors that could materially affect actual results can be found in Personalis' filings with the U.S. Securities and Exchange Commission, including Personalis' most recent reports on Forms 8-K, 10-K and 10-Q, the company's registration statement on Form S-3 filed on December 30, 2020, and the company's prospectus supplement filed on January 27, 2021, and include those listed under the caption "Risk Factors." Personalis disclaims any obligation to update such forward-looking statements.

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  16. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, today announced a collaboration with MapKure, LLC, a clinical-stage company focusing on genetically defined disease drivers and jointly owned by BeiGene, Ltd. and SpringWorks Therapeutics, Inc., to use a clinical trial assay (CTA) based on the Personalis® NeXT Platform™, an exome/transcriptome scale NGS-based assay, to support development of BGB-3245, an investigational next-generation B-RAF inhibitor, in patients with advanced or refractory solid tumors.

    As part of this collaboration MapKure will be working with Personalis to utilize the NeXT Platform as a confirmatory test for patients enrolled into MapKure's Phase 1a/1b dose escalation and expansion clinical trial…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, today announced a collaboration with MapKure, LLC, a clinical-stage company focusing on genetically defined disease drivers and jointly owned by BeiGene, Ltd. and SpringWorks Therapeutics, Inc., to use a clinical trial assay (CTA) based on the Personalis® NeXT Platform™, an exome/transcriptome scale NGS-based assay, to support development of BGB-3245, an investigational next-generation B-RAF inhibitor, in patients with advanced or refractory solid tumors.

    As part of this collaboration MapKure will be working with Personalis to utilize the NeXT Platform as a confirmatory test for patients enrolled into MapKure's Phase 1a/1b dose escalation and expansion clinical trial. Additionally, MapKure will benefit from the breadth of the NeXT Platform, which enables broad tumor immunogenomic profiling of the tumor and consolidates multiple biomarker assays into one, providing a multidimensional view of the tumor and its tumor microenvironment from a single sample, which will help MapKure understand if other biomarkers are clinically relevant to BGB-3245.

    "With new cancer immunotherapy and combination therapies, there is an increasing need for the development of more advanced composite biomarkers that can model the complex biology driving the response and resistance to cancer treatment. Our NeXT Platform provides biotechnology companies, like MapKure, with comprehensive genomic information from the entire exome and transcriptome, and provides information that can support the identification of new, advanced biomarkers. Once these biomarkers have been selected by MapKure, we expect to develop them as a companion diagnostic for regulatory submission and approval. We look forward to working with MapKure to accelerate the development of their cancer therapy in the clinic by utilizing the results from our NeXT Platform," said John West, CEO at Personalis.

    Financial terms of the collaboration were not disclosed.

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency, and quality. Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to the VA MVP. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis NeXT Platform is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. The Personalis Clinical Laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).

    About MapKure

    MapKure is a clinical-stage company created in 2019 to develop precision medicines for patients with life-threatening diseases, with an initial focus on cancer. By focusing on genetically defined disease drivers, MapKure is positioned to advance the development of transformative medicines to patients whose unmet medical needs are largely unaddressed. MapKure is jointly owned by BeiGene, Ltd. and SpringWorks Therapeutics, Inc., and is currently developing BGB-3245 under an exclusive license from BeiGene in solid tumor patients harboring specific B-RAF driver mutations and fusions, as well as in patients who have developed resistance to first-generation B-RAF inhibitors.

    Forward-Looking Statements

    All statements in this press release that are not historical are "forward-looking statements" within the meaning of U.S. securities laws, including statements relating to attributes or advantages of the Personalis NeXT Platform or the NeXT Dx Test, the expected benefits (including the potential for clinical trial use, companion diagnostic development and regulatory filings based on the company's NeXT Platform or the NeXT Dx Test) of the company's collaboration with MapKure, the company's business opportunities, leadership or growth, or other future events. Such forward-looking statements involve risks and uncertainties, including those related to the COVID-19 pandemic, that could cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements. Factors that could materially affect actual results can be found in Personalis' filings with the U.S. Securities and Exchange Commission, including Personalis' most recent reports on Forms 8-K, 10-K and 10-Q, the company's registration statement on Form S-3 filed on December 30, 2020, and the company's prospectus supplement filed on January 27, 2021, and include those listed under the caption "Risk Factors." Personalis disclaims any obligation to update such forward-looking statements.

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  17. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for population sequencing and cancer, today announced that it has appointed Dr. Woodrow (Woody) Myers to its Board of Directors and to the Nominating and Corporate Governance Committee of the Board. The company also announced that Patrick J. Balthrop has resigned his position as a director of the company, effective March 8, 2021.

    Dr. Myers is currently the managing director of Myers Ventures LLC and has a long and distinguished career in the healthcare industry, most recently serving as the Chief Medical Officer and Chief Healthcare Strategist at Blue Cross & Blue Shield of Arizona. He has also held executive positions with Havencrest Healthcare Partners, Corizon Health, and Wellpoint…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for population sequencing and cancer, today announced that it has appointed Dr. Woodrow (Woody) Myers to its Board of Directors and to the Nominating and Corporate Governance Committee of the Board. The company also announced that Patrick J. Balthrop has resigned his position as a director of the company, effective March 8, 2021.

    Dr. Myers is currently the managing director of Myers Ventures LLC and has a long and distinguished career in the healthcare industry, most recently serving as the Chief Medical Officer and Chief Healthcare Strategist at Blue Cross & Blue Shield of Arizona. He has also held executive positions with Havencrest Healthcare Partners, Corizon Health, and Wellpoint Health Networks. He has served on multiple public, private, and nonprofit boards including Express Scripts, Genomic Health, LipoScience, and SynGen. In higher education he served on the Board of Trustees of Stanford University, the Board of Overseers of Harvard University, and the Board of Trustees of the Charles R. Drew University of Medicine and Science.

    Dr. Myers has also been active in government, having served as physician health advisor to the United States Senate Committee on Labor and Human Resources, as Health Commissioner for his home state of Indiana, and as the Commissioner of Health for the City of New York.

    Dr. Myers holds a B.S. in Biological Science from Stanford University, and a medical degree (M.D.) from Harvard University. After medical school, he returned to Stanford for his internship, residency and clinical fellowship and, during this time, also completed his M.B.A. at Stanford. Dr. Myers is board-certified in internal medicine and his achievements in medical practice have earned him numerous honors including master, American College of Physicians, member, National Academy of Medicine, and fellow, American Association for Physician Leadership (formerly the American College of Physician Executives).

    "I am pleased to join the Board of Personalis at this exciting time in its history. The company's strategic focus on precision medicine is something I'm passionate about and I'm looking forward to helping achieve the vision of the Personalis team," said Dr. Myers.

    "I am excited to welcome Woody to the Board of Personalis," said John West, CEO of Personalis. "His extensive experience in the healthcare industry will be exceedingly valuable as we work towards our vision of genomics-driven medicine."

    "I am delighted to have Woody join our Board of Directors, as his considerable experience as a healthcare executive and his experience in medicine, business and health policy will be a tremendous asset as the company moves forward and continues executing on our strategic plan," said Jonathan MacQuitty, Ph.D., Chairman of the Board of Personalis. "Also, on behalf of my fellow directors, the company's management team, and shareholders, I would like to thank Pat for the significant contributions he made during his many years of service on the Personalis Board, including as founding chair of the Nominating and Corporate Governance Committee."

    About Personalis

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to the VA MVP. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. The Personalis Clinical Laboratory is GxP-aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).

    Forward-Looking Statements

    All statements in this press release that are not historical are "forward-looking statements" within the meaning of U.S. securities laws, including statements relating to attributes or advantages of the Personalis NeXT Platform, Personalis' business opportunities, leadership, plans, vision or growth, or other future events. Such forward-looking statements involve risks and uncertainties, including those related to the COVID-19 pandemic, that could cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements. Factors that could materially affect actual results can be found in Personalis' filings with the U.S. Securities and Exchange Commission, including Personalis' most recent reports on Forms 8-K, 10-K and 10-Q, the company's registration statement on Form S-3 filed on December 30, 2020, and the company's prospectus supplement filed on January 27, 2021, and include those listed under the caption "Risk Factors." Personalis disclaims any obligation to update such forward-looking statements.

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  18. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for population sequencing and cancer, today reported financial results for the fourth quarter and full year ended December 31, 2020.

    Fourth Quarter Highlights

    • Record quarterly revenue of $20.2 million in the fourth quarter of 2020 compared with $18.2 million in the fourth quarter of 2019, an 11% increase
    • Record quarterly revenue of $7.6 million from biopharma and all other customers, excluding VA MVP, in the fourth quarter of 2020 compared with $4.4 million in the fourth quarter of 2019, a 73% increase
    • A total of 45 customers have placed orders for NeXT as of December 31, 2020, with 6 of those customers placing their first orders in the fourth quarter of 2020
    • Achieved milestone…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for population sequencing and cancer, today reported financial results for the fourth quarter and full year ended December 31, 2020.

    Fourth Quarter Highlights

    • Record quarterly revenue of $20.2 million in the fourth quarter of 2020 compared with $18.2 million in the fourth quarter of 2019, an 11% increase
    • Record quarterly revenue of $7.6 million from biopharma and all other customers, excluding VA MVP, in the fourth quarter of 2020 compared with $4.4 million in the fourth quarter of 2019, a 73% increase
    • A total of 45 customers have placed orders for NeXT as of December 31, 2020, with 6 of those customers placing their first orders in the fourth quarter of 2020
    • Achieved milestone of completing more than 100,000 whole human genomes sequenced under the VA MVP contract
    • Launched new neoantigen prediction capabilities (called SHERPA™ and NEOPS™) in the fourth quarter of 2020

    "I'm proud to say that we were able to report record revenue once again this quarter and achieved our first $20 million revenue quarter, despite the impact from the COVID-19 pandemic. Biopharma revenue was strong and was a record high as some customers pushed to complete projects before the end of the year," said John West, Chief Executive Officer. "Recently, we announced a partnership with Natera that further validates our NeXT platform as a best-in-class tissue-sequencing front end, capable of detecting mutations in cancer that conventional exomes often miss. It also complements our whole exome liquid biopsy offering that we launched in August 2020 and NeXT Personal, our Minimal Residual Disease (MRD) offering that we expect to launch in 2021, providing Personalis with access to three distinct areas in the rapidly growing cancer monitoring market."

    Fourth Quarter 2020 Financial Results

    Revenues were $20.2 million in the three months ended December 31, 2020, up 11% from $18.2 million in the same period of the prior year.

    Gross margin was 30.1% in the three months ended December 31, 2020, compared with 36.2% in the same period of the prior year.

    Operating expenses were $19.4 million in the three months ended December 31, 2020, compared with $13.8 million in the same period of the prior year.

    Net loss was $13.3 million in the three months ended December 31, 2020 and net loss per share was $0.34 based on a weighted-average basic and diluted share count of 39.0 million, compared with a net loss of $6.6 million and a net loss per share of $0.21 on a weighted-average basic and diluted share count of 31.2 million in the same period of the prior year.

    Cash, cash equivalents, and short-term investments were $203.3 million as of December 31, 2020.

    Full Year 2020 Financial Results

    Revenues were $78.6 million for the year ended December 31, 2020, up 21% from $65.2 million in 2019.

    Gross margin was 25.6% for the year ended December 31, 2020, compared with 33.9% in 2019.

    Operating expenses were $62.3 million for the year ended December 31, 2020, compared with $44.5 million in 2019.

    Net loss was $41.3 million for the year ended December 31, 2020 and net loss per share was $1.20 based on a weighted-average basic and diluted share count of 34.4 million, compared with a net loss of $25.1 million and a net loss per share of $1.39 on a weighted-average basic and diluted share count of 18.0 million in 2019.

    First Quarter 2021 Outlook

    Personalis expects the following for the first quarter of 2021:

    • Total Company revenues are expected to be approximately $20.3 million
    • Revenues from biopharma and all other customers, excluding VA MVP, are expected to be in the range of $5.6 million to $7.0 million
    • Net Loss is expected to be in the range of $14.0 million to $15.0 million

    Webcast and Conference Call Information

    Personalis will host a conference call to discuss the fourth quarter and full year 2020 financial results after market close on Thursday, February 25, 2021 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live over the phone by dialing (866) 220-8061 for U.S. callers or (470) 495-9168 for international callers, using the conference ID: 5065084. The live webinar can be accessed at https://investors.personalis.com.

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to the VA MVP. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue or blood sample. The Personalis Clinical Laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from the results predicted, and reported results should not be considered an indication of future performance. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as "estimate," "expect," "preliminary," "should," "target," "will," or "would" or similar expressions and the negatives of those terms. These statements include, but are not limited to, statements regarding the company's expectations for revenues and net loss for the first quarter of 2021. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks, uncertainties and other factors relate to, among others: the timing and pace of new orders from customers, including from the U.S. Department of Veterans Affairs Million Veteran Program, which was the company's largest customer in 2018, 2019, and 2020; the launch of new products and product features, such as NeXT Personal; the timing of tissue, blood, and other specimen sample receipts from customers, which can materially impact revenue quarter over quarter and year over year; whether orders for the NeXT Platform and revenues from biopharmaceutical customers increase in future periods; the success of Personalis' collaborations and the Natera partnership; the success of the company's international expansion plans; the evolution of cancer therapies and market adoption of the company's services; the company's expectations regarding future performance; and the ongoing COVID-19 pandemic, which may significantly impact the company's business and operations and the business and operations of our customers and suppliers. In addition, other potential risks and uncertainties that could cause actual results to differ from the results predicted include, among others, those risks and uncertainties included under the captions "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the period ended December 31, 2020 that will be filed after this earnings release, and risk factors included within the registration statement on Form S-3 filed December 30, 2020, and prospectus supplement filed on January 27, 2021. All information provided in this release is as of the date of this press release, and any forward-looking statements contained herein are based on assumptions that we believe to be reasonable as of this date. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. Personalis undertakes no duty to update this information unless required by law.

     

    PERSONALIS, INC.

    CONSOLIDATED STATEMENTS OF OPERATIONS

    (in thousands, except share and per share data)

     

     

     

    Three Months Ended December 31,

     

     

    Year Ended December 31,

     

     

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

     

     

    (unaudited)

     

     

     

     

     

     

     

     

     

    Revenues

     

    $

    20,176

     

     

    $

    18,154

     

     

    $

    78,648

     

     

    $

    65,207

     

    Costs and expenses

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Costs of revenues

     

     

    14,106

     

     

     

    11,589

     

     

     

    58,534

     

     

     

    43,127

     

    Research and development

     

     

    8,520

     

     

     

    7,373

     

     

     

    28,568

     

     

     

    22,418

     

    Selling, general and administrative

     

     

    10,920

     

     

     

    6,388

     

     

     

    33,692

     

     

     

    22,080

     

    Total costs and expenses

     

     

    33,546

     

     

     

    25,350

     

     

     

    120,794

     

     

     

    87,625

     

    Loss from operations

     

     

    (13,370

    )

     

     

    (7,196

    )

     

     

    (42,146

    )

     

     

    (22,418

    )

    Interest income

     

     

    76

     

     

     

    580

     

     

     

    949

     

     

     

    1,620

     

    Interest expense

     

     

     

     

     

     

     

     

    (2

    )

     

     

    (1,133

    )

    Loss on debt extinguishment

     

     

     

     

     

     

     

     

     

     

     

    (1,704

    )

    Other (expense) income, net

     

     

    (29

    )

     

     

    (25

    )

     

     

    (24

    )

     

     

    (1,440

    )

    Loss before income taxes

     

     

    (13,323

    )

     

     

    (6,641

    )

     

     

    (41,223

    )

     

     

    (25,075

    )

    Provision for income taxes

     

     

    (18

    )

     

     

    (4

    )

     

     

    (57

    )

     

     

    (9

    )

    Net loss

     

    $

    (13,341

    )

     

    $

    (6,645

    )

     

    $

    (41,280

    )

     

    $

    (25,084

    )

    Net loss per share, basic and diluted

     

    $

    (0.34

    )

     

    $

    (0.21

    )

     

    $

    (1.20

    )

     

    $

    (1.39

    )

    Weighted-average shares outstanding, basic and diluted

     

     

    38,962,860

     

     

     

    31,205,546

     

     

     

    34,374,903

     

     

     

    18,011,470

     

    PERSONALIS, INC.

    SUPPLEMENTAL REVENUE INFORMATION

    (in thousands)

     

     

     

    Three Months Ended December 31,

     

     

    Year Ended December 31,

     

     

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

     

     

    (unaudited)

     

     

     

     

     

     

     

     

     

    VA MVP

     

    $

    12,556

     

     

    $

    13,754

     

     

    $

    56,154

     

     

    $

    43,545

     

    All other customers

     

     

    7,620

     

     

     

    4,400

     

     

     

    22,494

     

     

     

    21,662

     

    Total

     

    $

    20,176

     

     

    $

    18,154

     

     

    $

    78,648

     

     

    $

    65,207

     

    PERSONALIS, INC.

    CONSOLIDATED BALANCE SHEETS

    (in thousands, except share and per share data)

     

     

     

    December 31,

     

     

    December 31,

     

     

     

    2020

     

     

    2019

     

    Assets

     

     

     

     

     

     

     

     

    Current assets

     

     

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    68,525

     

     

    $

    55,046

     

    Short-term investments

     

     

    134,765

     

     

     

    73,243

     

    Accounts receivable, net

     

     

    6,349

     

     

     

    3,300

     

    Inventory and other deferred costs

     

     

    5,639

     

     

     

    4,606

     

    Prepaid expenses and other current assets

     

     

    5,441

     

     

     

    3,383

     

    Total current assets

     

     

    220,719

     

     

     

    139,578

     

    Property and equipment, net

     

     

    11,834

     

     

     

    14,106

     

    Operating lease right-of-use assets

     

     

    10,271

     

     

     

    1,845

     

    Other long-term assets

     

     

    2,018

     

     

     

    1,762

     

    Total assets

     

    $

    244,842

     

     

    $

    157,291

     

    Liabilities and Stockholders' Equity

     

     

     

     

     

     

     

     

    Current liabilities

     

     

     

     

     

     

     

     

    Accounts payable

     

    $

    8,301

     

     

    $

    7,337

     

    Accrued and other current liabilities

     

     

    11,301

     

     

     

    6,648

     

    Contract liabilities

     

     

    21,034

     

     

     

    35,977

     

    Total current liabilities

     

     

    40,636

     

     

     

    49,962

     

    Long-term operating lease liabilities

     

     

    8,541

     

     

     

    639

     

    Other long-term liabilities

     

     

    720

     

     

     

     

    Total liabilities

     

     

    49,897

     

     

     

    50,601

     

    Commitments and Contingencies

     

     

     

     

     

     

     

     

    Stockholders' equity

     

     

     

     

     

     

     

     

    Preferred stock, $0.0001 par value — 10,000,000 shares authorized; none issued

     

     

     

     

     

     

    Common stock, $0.0001 par value — 200,000,000 shares authorized; 39,105,548 and 31,243,029 shares issued and outstanding at December 31, 2020 and 2019, respectively

     

     

    4

     

     

     

    3

     

    Additional paid-in capital

     

     

    376,788

     

     

     

    247,282

     

    Accumulated other comprehensive income (loss)

     

     

    22

     

     

     

    (6

    )

    Accumulated deficit

     

     

    (181,869

    )

     

     

    (140,589

    )

    Total stockholders' equity

     

     

    194,945

     

     

     

    106,690

     

    Total liabilities and stockholders' equity

     

    $

    244,842

     

     

    $

    157,291

     

     

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  19. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, and Natera, Inc. (NASDAQ:NTRA), a global leader in cell-free DNA testing, today announced that the two companies have entered into a partnership in the field of personalized oncology. The partnership will pair Personalis' NeXT tumor profiling and diagnostic products with Natera's personalized ctDNA platform Signatera™ for treatment monitoring and molecular residual disease (MRD) assessment.

    Under this non-exclusive agreement, Natera will validate the design of Signatera personalized ctDNA assays using matched tumor and normal exome sequence data from Personalis, and Natera will be responsible for commercialization. The agreement covers MRD testing for both clinical use…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, and Natera, Inc. (NASDAQ:NTRA), a global leader in cell-free DNA testing, today announced that the two companies have entered into a partnership in the field of personalized oncology. The partnership will pair Personalis' NeXT tumor profiling and diagnostic products with Natera's personalized ctDNA platform Signatera™ for treatment monitoring and molecular residual disease (MRD) assessment.

    Under this non-exclusive agreement, Natera will validate the design of Signatera personalized ctDNA assays using matched tumor and normal exome sequence data from Personalis, and Natera will be responsible for commercialization. The agreement covers MRD testing for both clinical use and research use.

    "This represents another step forward in Natera's vision for Signatera, as a personalized monitoring and MRD platform that can be scaled and integrated robustly with high-quality exome-scale tissue sequencing assays worldwide, of which Personalis' NeXT is a leading example," commented Solomon Moshkevich, Natera's General Manager of Oncology. "We are pleased to partner with them and to expand access of Signatera to a new set of potential customers."

    "The NeXT Platform™ complements Signatera by offering advanced tumor analysis with augmented coverage across all 20,000 genes," said Richard Chen, Chief Scientific Officer of Personalis. "We are excited to partner with Natera on this sensitive tumor-informed approach to accelerate molecular residual disease detection in cancer."

    About Natera

    Natera is a pioneer and global leader in cell-free DNA testing from a simple blood draw. The mission of the company is to change the management of disease worldwide with a focus on women's health, oncology, and organ health. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, California and Austin, Texas. It offers proprietary genetic testing services to inform obstetricians, transplant physicians, oncologists, and cancer researchers, including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit natera.com. Follow Natera on LinkedIn.

    Forward-Looking Statements

    All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera's plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers, or our ability to successfully execute the partnership. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera's recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

    Natera Contacts

    Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350

    Media: Paul Greenland, VP of Corporate Marketing, Natera, Inc., pr@natera.com

    About Personalis

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to the VA MVP. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. The Personalis Clinical Laboratory is GxP-aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).

    Forward-Looking Statements

    All statements in this press release that are not historical are "forward-looking statements" within the meaning of U.S. securities laws, including statements relating to attributes or advantages of the Personalis NeXT Platform (including with respect to its pairing with the Signatera platform), expected benefits from the partnership between Personalis and Natera, Personalis' business opportunities, leadership or growth, or other future events. Such forward-looking statements involve risks and uncertainties, including those related to the COVID-19 pandemic, that could cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements. Factors that could materially affect actual results can be found in Personalis' filings with the U.S. Securities and Exchange Commission, including Personalis' most recent reports on Forms 8-K, 10-K and 10-Q, the company's registration statement on Form S-3 filed on December 30, 2020, and the company's prospectus supplement filed on January 27, 2021, and include those listed under the caption "Risk Factors." Personalis disclaims any obligation to update such forward-looking statements.

    View Full Article Hide Full Article
  20. SAN CARLOS, Calif. and MENLO PARK, Calif., Feb. 17, 2021 /PRNewswire/ -- Natera, Inc. (NASDAQ:NTRA), a global leader in cell-free DNA testing, and Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, today announced that the two companies have entered into a partnership in the field of personalized oncology. The partnership will pair Personalis' NeXT tumor profiling and diagnostic products with Natera's personalized ctDNA platform Signatera™ for treatment monitoring and molecular residual disease (MRD) assessment.

    Under this non-exclusive agreement, Natera will validate the design of Signatera personalized ctDNA assays using matched tumor and normal exome sequence data from Personalis, and Natera will be responsible for commercialization. The agreement covers MRD testing for both clinical use and research use.

    "This represents another step forward in Natera's vision for Signatera, as a personalized monitoring and MRD platform that can be scaled and integrated robustly with high-quality exome-scale tissue sequencing assays worldwide, of which Personalis' NeXT is a leading example," commented Solomon Moshkevich, Natera's General Manager of Oncology. "We are pleased to partner with them and to expand access of Signatera to a new set of potential customers."

    "The NeXT Platform™ complements Signatera by offering advanced tumor analysis with augmented coverage across all 20,000 genes," said Richard Chen, Chief Scientific Officer of Personalis. "We are excited to partner with Natera on this sensitive tumor-informed approach to accelerate molecular residual disease detection in cancer."

    About Natera

    Natera is a pioneer and global leader in cell-free DNA testing from a simple blood draw. The mission of the company is to change the management of disease worldwide with a focus on women's health, oncology, and organ health. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, California and Austin, Texas. It offers proprietary genetic testing services to inform obstetricians, transplant physicians, oncologists, and cancer researchers, including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit natera.com. Follow Natera on LinkedIn.

    Forward-Looking Statements

    All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera's plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers, or our ability to successfully execute the partnership. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera's recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

    Natera Contacts

    Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350

    Media: Paul Greenland, VP of Corporate Marketing, Natera, Inc., pr@natera.com

    About Personalis

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to the VA MVP. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. The Personalis Clinical Laboratory is GxP-aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).

    Forward-Looking Statements

    All statements in this press release that are not historical are "forward-looking statements" within the meaning of U.S. securities laws, including statements relating to attributes or advantages of the Personalis NeXT Platform (including with respect to its pairing with the Signatera platform), expected benefits from the partnership between Personalis and Natera, Personalis' business opportunities, leadership or growth, or other future events. Such forward-looking statements involve risks and uncertainties, including those related to the COVID-19 pandemic, that could cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements. Factors that could materially affect actual results can be found in Personalis' filings with the U.S. Securities and Exchange Commission, including Personalis' most recent reports on Forms 8-K, 10-K and 10-Q, the company's registration statement on Form S-3 filed on December 30, 2020, and the company's prospectus supplement filed on January 27, 2021, and include those listed under the caption "Risk Factors." Personalis disclaims any obligation to update such forward-looking statements.

    Contacts for Personalis, Inc.

    Investor Relations Contact for Personalis:

    Caroline Corner

    investors@personalis.com 

    415-202-5678

    Media Contact for Personalis:

    Jennifer Havlek

    pr@personalis.com 

    www.personalis.com

    650-752-1300

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/natera-and-personalis-partner-for-personalized-monitoring-in-oncology-301229656.html

    SOURCE Natera, Inc.

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  21. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, announced today that its management team will present at the following upcoming investor conferences:

    • Cowen 41st Annual Healthcare Conference
      Presenting on Tuesday, March 2, 2021 at 1:30 p.m. Eastern Time
    • Barclays Global Healthcare Conference
      Presenting on Wednesday, March 10, 2021 at 11:30 a.m. Eastern Time

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing programs globally and is currently the sole sequencing provider to the U.S. Department of Veterans Affairs Million Veterans Program. In oncology, Personalis is…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, announced today that its management team will present at the following upcoming investor conferences:

    • Cowen 41st Annual Healthcare Conference

      Presenting on Tuesday, March 2, 2021 at 1:30 p.m. Eastern Time
    • Barclays Global Healthcare Conference

      Presenting on Wednesday, March 10, 2021 at 11:30 a.m. Eastern Time

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing programs globally and is currently the sole sequencing provider to the U.S. Department of Veterans Affairs Million Veterans Program. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue or blood sample. The Personalis® Clinical Laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited.

    View Full Article Hide Full Article
  22. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, announced today it will release its fourth quarter 2020 financial results after the market closes on Thursday, February 25, 2021. In conjunction with the release, the Company will host a conference call and webcast that day at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss its financial results and recent highlights.

    Interested parties may access the live call via telephone by dialing (866) 990-1997 for domestic callers or (470) 495-9127 for international callers, using conference ID: 5065084. The live webinar of the call may be accessed by visiting the Events section of the company's website at investors.personalis.com. A replay of the webinar will be available…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, announced today it will release its fourth quarter 2020 financial results after the market closes on Thursday, February 25, 2021. In conjunction with the release, the Company will host a conference call and webcast that day at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss its financial results and recent highlights.

    Interested parties may access the live call via telephone by dialing (866) 990-1997 for domestic callers or (470) 495-9127 for international callers, using conference ID: 5065084. The live webinar of the call may be accessed by visiting the Events section of the company's website at investors.personalis.com. A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company's website.

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing programs globally and is currently the sole sequencing provider to the U.S. Department of Veterans Affairs Million Veterans Program. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue or blood sample. The Personalis® Clinical Laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited.

    View Full Article Hide Full Article
  23. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for population sequencing and cancer, today announced the appointment of Susan Moriconi as VP of People and Chief Human Resources Officer.

    Ms. Moriconi joins Personalis from Omnicell, Inc. (NASDAQ:OMCL), where she most recently served as Senior Vice President, Chief Human Resources Officer, and was responsible for global recruiting, employee engagement, talent management, diversity and inclusion, compensation and benefits, HR technology, internal communications and employee development. During her tenure with Omnicell, Ms. Moriconi oversaw scaling from 800 to over 2,700 employees, expanded office locations from 5 to 19 locations in 9 countries, while company revenues grew from approximately…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for population sequencing and cancer, today announced the appointment of Susan Moriconi as VP of People and Chief Human Resources Officer.

    Ms. Moriconi joins Personalis from Omnicell, Inc. (NASDAQ:OMCL), where she most recently served as Senior Vice President, Chief Human Resources Officer, and was responsible for global recruiting, employee engagement, talent management, diversity and inclusion, compensation and benefits, HR technology, internal communications and employee development. During her tenure with Omnicell, Ms. Moriconi oversaw scaling from 800 to over 2,700 employees, expanded office locations from 5 to 19 locations in 9 countries, while company revenues grew from approximately $250 million to almost $900 million. Earlier in her career, Ms. Moriconi served as VP of HR at several established healthcare and technology companies – including Boston Scientific, Stanford Healthcare, and the not-for-profit pharmaceutical Institute for OneWorld Health. She holds a BA from University of the Pacific and an MBA in Marketing from Santa Clara University.

    "Susan Moriconi brings over 20 years of experience in human resources and organization strategy, including deep experience in the life sciences industry. She is the right leader to help expand our company and continue to build an engaged, inclusive, and high-performing culture at Personalis," said John West, Personalis CEO. "We are excited to welcome her to Personalis."

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to the VA MVP. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. The Personalis Clinical Laboratory is GxP-aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).

    Forward-Looking Statements

    All statements in this press release that are not historical are "forward-looking statements" within the meaning of U.S. securities laws, including statements relating to attributes or advantages of the Personalis NeXT Platform, the company's business opportunities, leadership or growth, or other future events. Such forward-looking statements involve risks and uncertainties, including those related to the COVID-19 pandemic, that could cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements. Factors that could materially affect actual results can be found in Personalis' filings with the U.S. Securities and Exchange Commission, including the company's most recent reports on Forms 8-K, 10-K and 10-Q, the company's shelf registration statement on Form S-3 filed on December 30, 2020, and the company's prospectus supplement related to its recent public offering filed on January 27, 2021, and include those listed under the caption "Risk Factors." Personalis disclaims any obligation to update such forward-looking statements.

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  24. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, announced today that its management team will present at the BTIG Virtual MedTech, Digital Health, Life Science and Diagnostic Tools Conference on Thursday, February 18, 2021 at 12:00 p.m. Eastern Time.

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing programs globally and is currently the sole sequencing provider to the U.S. Department of Veterans Affairs Million Veterans Program. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, announced today that its management team will present at the BTIG Virtual MedTech, Digital Health, Life Science and Diagnostic Tools Conference on Thursday, February 18, 2021 at 12:00 p.m. Eastern Time.

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing programs globally and is currently the sole sequencing provider to the U.S. Department of Veterans Affairs Million Veterans Program. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue or blood sample. The Personalis® Clinical Laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited.

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  25. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for population sequencing and cancer, today announced the pricing of its previously announced underwritten public offering of 3,950,000 shares of its common stock at a price to the public of $38.00 per share. Gross proceeds to Personalis from the offering are expected to be $150.1 million, before deducting underwriting discounts and commissions and estimated offering expenses.

    In addition, the underwriters have been granted a 30-day option to purchase up to an additional 592,500 shares of common stock from Personalis on the same terms and conditions.

    Morgan Stanley, BofA Securities, Citigroup and Cowen are acting as joint book-running managers. BTIG is acting as co-manager.

    A…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for population sequencing and cancer, today announced the pricing of its previously announced underwritten public offering of 3,950,000 shares of its common stock at a price to the public of $38.00 per share. Gross proceeds to Personalis from the offering are expected to be $150.1 million, before deducting underwriting discounts and commissions and estimated offering expenses.

    In addition, the underwriters have been granted a 30-day option to purchase up to an additional 592,500 shares of common stock from Personalis on the same terms and conditions.

    Morgan Stanley, BofA Securities, Citigroup and Cowen are acting as joint book-running managers. BTIG is acting as co-manager.

    A shelf registration statement relating to the shares being sold in this offering was filed with the U.S. Securities and Exchange Commission on December 30, 2020, and was declared effective on January 8, 2021. A preliminary prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC and are available for free on the SEC's website located at http://www.sec.gov. When available, electronic copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; BofA Securities, Attention: Prospectus Department, NC1‐004‐03‐43, 200 North College Street, 3rd floor, Charlotte, NC 28255‐0001, or by emailing dg.prospectus_requests@bofa.com; Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-800-831-9146; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: 1-833-297-2926.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing programs globally and is currently the sole sequencing provider to the U.S. Department of Veterans Affairs Million Veterans Program. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue or blood sample. The Personalis® Clinical Laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited.

    Forward-Looking Statements

    This press release contains forward-looking statements, including statements relating to Personalis' expectations regarding the underwritten public offering. These statements are subject to significant risks and uncertainties and actual results could differ materially from those projected. Personalis cautions investors not to place undue reliance on the forward-looking statements contained in this release. These risks and uncertainties include, without limitation, the fact that completion of the underwritten public offering is subject to the satisfaction of customary closing conditions. Risks and uncertainties relating to Personalis and its business can be found in the "Risk Factors" sections of Personalis' Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on November 5, 2020, the shelf registration statement filed with the SEC on December 30, 2020, the preliminary prospectus supplement related to the public offering filed with the SEC on January 26, 2021, and the final prospectus supplement related to the public offering to be filed with the SEC on or about January 27, 2021. Personalis undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in Personalis' expectations, except as required by law.

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  26. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for population sequencing and cancer, today announced that it has commenced an underwritten public offering of $150.0 million of its common stock. In addition, Personalis expects to grant the underwriters a 30-day option to purchase up to an additional $22.5 million of common stock on the same terms and conditions.

    The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering.

    Morgan Stanley, BofA Securities, Citigroup and Cowen are acting as joint book-running managers. BTIG is acting as co-manager.

    A shelf registration statement relating to the shares being sold…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for population sequencing and cancer, today announced that it has commenced an underwritten public offering of $150.0 million of its common stock. In addition, Personalis expects to grant the underwriters a 30-day option to purchase up to an additional $22.5 million of common stock on the same terms and conditions.

    The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering.

    Morgan Stanley, BofA Securities, Citigroup and Cowen are acting as joint book-running managers. BTIG is acting as co-manager.

    A shelf registration statement relating to the shares being sold in this offering was filed with the U.S. Securities and Exchange Commission on December 30, 2020, and was declared effective on January 8, 2021. The offering will be made only by means of a prospectus supplement and accompanying prospectus. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available for free on the SEC's website located at http://www.sec.gov. When available, electronic copies of the preliminary prospectus supplement and accompanying prospectus relating to the proposed public offering may be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; BofA Securities, Attention: Prospectus Department, NC1‐004‐03‐43, 200 North College Street, 3rd floor, Charlotte, NC 28255‐0001, or by emailing dg.prospectus_requests@bofa.com; Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-800-831-9146; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: 1-833-297-2926.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing programs globally and is currently the sole sequencing provider to the U.S. Department of Veterans Affairs Million Veterans Program. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue or blood sample. The Personalis® Clinical Laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited.

    Forward-Looking Statements

    This press release contains forward-looking statements, including statements relating to Personalis' expectations regarding the proposed public offering. These statements are subject to significant risks and uncertainties and actual results could differ materially from those projected. Personalis cautions investors not to place undue reliance on the forward-looking statements contained in this release. These risks and uncertainties include, without limitation, risks and uncertainties related to market conditions, the risk that the proposed public offering will not be consummated on the terms or in the amounts contemplated or otherwise, and the satisfaction of customary closing conditions related to the proposed public offering. Risks and uncertainties relating to Personalis and its business can be found in the "Risk Factors" sections of Personalis' Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on November 5, 2020, the self registration statement filed with the SEC on December 30, 2020 and the preliminary prospectus supplement related to the proposed public offering filed with the SEC on January 26, 2021. Personalis undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in Personalis' expectations, except as required by law.

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  27. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for population sequencing and cancer, today reported unaudited preliminary revenue for the fourth quarter and full year ended December 31, 2020.

    Personalis estimates revenue of approximately $20.2 million for the fourth quarter of 2020 compared with $18.2 million in the fourth quarter of 2019, representing an increase of 11%. For the full year 2020, revenue is estimated to be approximately $78.6 million compared with $65.2 million for 2019, representing an increase of 21%.

    Fourth Quarter Highlights

    • Preliminary revenue from biopharma and all other customers of an estimated $7.6 million in the fourth quarter of 2020 compared with $4.4 million in the fourth quarter of 2019, a 73…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for population sequencing and cancer, today reported unaudited preliminary revenue for the fourth quarter and full year ended December 31, 2020.

    Personalis estimates revenue of approximately $20.2 million for the fourth quarter of 2020 compared with $18.2 million in the fourth quarter of 2019, representing an increase of 11%. For the full year 2020, revenue is estimated to be approximately $78.6 million compared with $65.2 million for 2019, representing an increase of 21%.

    Fourth Quarter Highlights

    • Preliminary revenue from biopharma and all other customers of an estimated $7.6 million in the fourth quarter of 2020 compared with $4.4 million in the fourth quarter of 2019, a 73% increase
    • Preliminary revenue from the U.S. Department of Veterans Affairs Million Veterans Program (VA MVP) of an estimated $12.6 million in the fourth quarter of 2020 compared with $13.8 million in the fourth quarter of 2019, a decrease of 9%
    • Preliminary cash, cash equivalents, and short-term investments were estimated to be $203 million as of December 31, 2020
    • A total of 45 customers have placed orders for NeXT as of December 31, 2020, with 6 of those customers placing their first orders in the fourth quarter of 2020
    • Achieved milestone of completing more than 100,000 whole human genomes sequenced under the VA MVP contract
    • Launch of SHERPA™ and NEOPS™ (neoantigen prediction capability) in the fourth quarter of 2020

    "I'm proud to say that we were able to report record revenue once again this quarter and achieved our first $20 million revenue quarter, despite the impact from the COVID-19 pandemic. Biopharma revenue was strong and customer orders were once again above revenue reported," said John West, Chief Executive Officer. "In addition, we have several customers that have placed orders for our liquid biopsy offering, which we expect will be an important driver of growth in the future."

    The above information is preliminary and subject to Personalis' normal quarter and year-end accounting procedures and external audit by the company's independent registered public accounting firm.

    Webcast and Conference Call Information

    Personalis will issue a press release with final financial results and host a conference call to discuss the fourth quarter and full year 2020 financial results after market close on Thursday, February 25, 2021 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live over the phone by dialing (866) 220-8061 for U.S. callers or (470) 495-9168 for international callers, using the conference ID: 5065084. The live webinar can be accessed at https://investors.personalis.com.

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics company, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to the VA MVP. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue or blood sample. The Personalis Clinical Laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).

    Forward-Looking Statements

    The company has not completed the audit of its 2020 financial results nor filed its Annual Report on Form 10-K for the year ended December 31, 2020. As a result, all financial results described in this press release should be considered preliminary and are subject to change to reflect any necessary corrections or adjustments, or changes in accounting estimates, that are identified prior to completion of this audit and the company's Annual Report on Form 10-K for the year ended December 31, 2020. Actual results could differ materially from these preliminary results.

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from the results predicted, and reported results should not be considered as an indication of future performance. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as "estimate," "expect," "preliminary," "should," "target," "will," or "would" or similar expressions and the negatives of those terms. These statements include, but are not limited to, statements regarding the company's estimated revenues for the fourth quarter of 2020 and the full year of 2020, and preliminary cash, cash equivalents, and short-term investments as of December 31, 2020. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks, uncertainties and other factors relate to, among others: additional adjustments to our expected fourth quarter of 2020 and full year 2020 revenue that may be identified during our regular financial closing and audit procedures and other developments, the timing and pace of new orders from customers; the launch of new products and product features; the timing of tissue, blood, and other specimen sample receipts from customers, which can materially impact revenue quarter over quarter and year over year; whether orders for the NeXT platform and revenues from biopharmaceutical customers will increase; the success of Personalis' collaborations and partnerships; the success of the company's international expansion plans; the evolution of cancer therapies and market adoption of the company's services; the company's expectations regarding future performance; and the COVID-19 pandemic, which may significantly impact the company's business and operations and the business and operations of our customers and suppliers. In addition, other potential risks and uncertainties that could cause actual results to differ from the results predicted include, among others, those risks and uncertainties included under the captions "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Quarterly Report on Form 10-Q for the period ended September 30, 2020, and risk factors included within the registration statement on Form S-3 filed December 30, 2020. All information provided in this release is as of the date of this press release, and any forward-looking statements contained herein are based on assumptions that we believe to be reasonable as of this date. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. Personalis undertakes no duty to update this information unless required by law.

    PERSONALIS, INC.

    PRELIMINARY REVENUE RESULTS (unaudited)

    (in thousands)

     

     

    Three Months Ended December 31,

    Year Ended December 31,

     

    2020

    2019

    2020

    2019

     

    (preliminary)

     

     

    (preliminary)

     

     

    VA MVP

    $

    12,556

    $

    13,754

    $

    56,154

    $

    43,545

    All other customers

     

    7,620

     

    4,400

     

    22,494

     

    21,662

    Total

    $

    20,176

    $

    18,154

    $

    78,648

    $

    65,207

     

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  28. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, today announced that management will present at the 23rd Annual Needham Virtual Growth Conference on Wednesday, January 13, 2021 at 2:45 p.m. Eastern Time.

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to the VA MVP. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis®ImmunoID NeXT Platform® is designed to adapt…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, today announced that management will present at the 23rd Annual Needham Virtual Growth Conference on Wednesday, January 13, 2021 at 2:45 p.m. Eastern Time.

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to the VA MVP. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. The Personalis Clinical Laboratory is GxP-aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).

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  29. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, today announced the launch of its proprietary Neoantigen Presentation Score (NEOPS). NEOPS combines analysis from Personalis' state-of-the-art tumor neoantigen prediction tool, SHERPA™, with mechanisms of immune evasion to better predict response to cancer therapy.

    NEOPS combines the tumor genomic and immune-related analytics of the Personalis® NeXT Platform™ to create a composite biomarker that can be more effective in predicting immunotherapy response than other, simpler biomarkers. NEOPS leverages Personalis' recently-launched machine learning-based tool, Systematic HLA Epitope Ranking Pan Algorithm (SHERPA), which provides more accurate prediction of neoantigen presentation…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, today announced the launch of its proprietary Neoantigen Presentation Score (NEOPS). NEOPS combines analysis from Personalis' state-of-the-art tumor neoantigen prediction tool, SHERPA™, with mechanisms of immune evasion to better predict response to cancer therapy.

    NEOPS combines the tumor genomic and immune-related analytics of the Personalis® NeXT Platform™ to create a composite biomarker that can be more effective in predicting immunotherapy response than other, simpler biomarkers. NEOPS leverages Personalis' recently-launched machine learning-based tool, Systematic HLA Epitope Ranking Pan Algorithm (SHERPA), which provides more accurate prediction of neoantigen presentation, a core mechanism in determining immunotherapy response.

    Data presented at the AACR virtual meeting in June demonstrated that NEOPS significantly outperformed tumor mutational burden in predicting response to anti-PD-L1 therapy in a cohort of late-stage, unresectable melanoma patients, highlighting the potential of composite, neoantigen-based biomarkers to more effectively stratify responders and non-responders to immunotherapy. The prevalence of immune evasion events incorporated into NEOPS suggests that such composite neoantigen-based biomarkers are potentially applicable to a range of immunotherapies and cancer types.

    "Identifying effective biomarkers for cancer immunotherapy has proven challenging due to the complex biological mechanisms underlying patient response. We believe that more sophisticated, multimodal biomarker models like NEOPS represent the next step in this pursuit. By combining accurate tumor neoantigen prediction with mechanisms of immune evasion, we can create a more predictive model of therapy response," said Richard Chen, MD, Personalis CSO. "NEOPS is the first of a new class of composite biomarkers for our pharma partners to utilize in their clinical trials. In the future, such biomarkers may be used to inform treatment decisions for patients."

    NEOPS, SHERPA, and other recent enhancements to the company's HLA typing and HLA LOH analytics represent the latest update to the comprehensive suite of advanced analytical engines of the Personalis NeXT Platform™. Utilizing an augmented exome and transcriptome-based approach, NeXT enables the simultaneous analysis of both a tumor and its immune microenvironment from a single tumor specimen to explore critical immunotherapy-related resistance mechanisms and novel composite biomarkers of response.

    About Personalis, Inc.

    Personalis, Inc. is a leader in cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing operations globally. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis NeXT Platform is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. The Personalis Clinical Laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).

    Forward-Looking Statements

    All statements in this press release that are not historical are "forward-looking statements" within the meaning of U.S. securities laws, including statements relating to attributes or advantages of NEOPS, SHERPA or the Personalis NeXT Platform, the company's business opportunities, leadership or growth, or other future events. Such forward-looking statements involve risks and uncertainties, including those related to the COVID-19 pandemic, that could cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements. Factors that could materially affect actual results can be found in Personalis' filings with the U.S. Securities and Exchange Commission, including the company's most recent reports on Forms 8-K, 10-K and 10-Q, and include those listed under the caption "Risk Factors." Personalis disclaims any obligation to update such forward-looking statements.

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  30. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, today announced the launch of its Systematic HLA Epitope Ranking Pan Algorithm (SHERPA), the company's proprietary, machine learning-based tool for the comprehensive identification and characterization of cancer neoantigens. Integrated into the Personalis® NeXT Platform™, SHERPA enables the development of new neoantigen-based diagnostic biomarkers, such as the company's proprietary Neoantigen Presentation Score (NEOPS™), and novel personalized therapies.

    Data presented at the SITC Annual Meeting in November 2020 showed SHERPA outperforming commonly used neoantigen binding prediction tools in clinical tumor samples. "With more accurate neoantigen presentation prediction…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, today announced the launch of its Systematic HLA Epitope Ranking Pan Algorithm (SHERPA), the company's proprietary, machine learning-based tool for the comprehensive identification and characterization of cancer neoantigens. Integrated into the Personalis® NeXT Platform™, SHERPA enables the development of new neoantigen-based diagnostic biomarkers, such as the company's proprietary Neoantigen Presentation Score (NEOPS™), and novel personalized therapies.

    Data presented at the SITC Annual Meeting in November 2020 showed SHERPA outperforming commonly used neoantigen binding prediction tools in clinical tumor samples. "With more accurate neoantigen presentation prediction, we are looking to enable a new generation of precision oncology applications," said Richard Chen, MD, Personalis CSO. "Trained on a proprietary immunopeptidomics dataset derived from engineered cell lines, SHERPA improves neoantigen presentation prediction compared to other in silico methods. With this advancement, SHERPA can enable more predictive biomarkers for cancer therapy as well as facilitate the development of neoantigen-targeting, personalized cancer therapies. Our recently-launched NEOPS is one example of a SHERPA-derived composite biomarker that has shown promise in predicting immunotherapy response in cancer patients."

    While most conventional in silico methods generally only assess the potential MHC-binding affinity and stability of identified peptides, SHERPA goes a step further by incorporating features relating to the antigen processing machinery and RNA abundance to generate a presentation rank for each detected peptide. This serves to determine the relative likelihood of a given neoantigen being presented and undergoing immunosurveillance.

    This launch represents the broader commercial release of SHERPA, which is currently being leveraged by Personalis' preferred partner, Sarepta Therapeutics, to characterize immune response to precision genetic therapeutics in patients with rare diseases, demonstrating the applicability of this machine learning tool in disease areas beyond cancer.

    About Personalis, Inc.

    Personalis, Inc. is a leader in cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing operations globally. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis NeXT Platform is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. The Personalis Clinical Laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).

    Forward-Looking Statements

    All statements in this press release that are not historical are "forward-looking statements" within the meaning of U.S. securities laws, including statements relating to attributes or advantages of SHERPA, NEOPS or the Personalis NeXT Platform, the company's business opportunities, leadership or growth, or other future events. Such forward-looking statements involve risks and uncertainties, including those related to the COVID-19 pandemic, that could cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements. Factors that could materially affect actual results can be found in Personalis' filings with the U.S. Securities and Exchange Commission, including the company's most recent reports on Forms 8-K, 10-K and 10-Q, and include those listed under the caption "Risk Factors." Personalis disclaims any obligation to update such forward-looking statements.

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  31. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for population sequencing and cancer, announced today that it has delivered the 100,000th whole human genome sequence dataset to the U.S. Department of Veterans Affairs Million Veteran Program (VA MVP). Although Personalis has been contracted by the VA MVP since 2012, the program has accelerated and over 50,000 of these genomes have been delivered in 2020.

    "The VA MVP is the largest whole genome sequencing project in the United States and this is a significant milestone for both the program and for Personalis," said John West, Chief Executive Officer. "Population-scale sequencing projects of this nature represent a cornerstone in our effort to accelerate the advancement of precision…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for population sequencing and cancer, announced today that it has delivered the 100,000th whole human genome sequence dataset to the U.S. Department of Veterans Affairs Million Veteran Program (VA MVP). Although Personalis has been contracted by the VA MVP since 2012, the program has accelerated and over 50,000 of these genomes have been delivered in 2020.

    "The VA MVP is the largest whole genome sequencing project in the United States and this is a significant milestone for both the program and for Personalis," said John West, Chief Executive Officer. "Population-scale sequencing projects of this nature represent a cornerstone in our effort to accelerate the advancement of precision medicine across a wide range of disease areas. With our sizable investments in the technology and infrastructure, necessary to win and execute these projects, Personalis sees population genomics and health as key priorities for our company. We congratulate the VA MVP for their visionary leadership and note that VA scientists now list over 50 peer reviewed publications from the Program."

    Earlier this year, the company strengthened its commitment to this application area with the appointment of Mr. Kevin Dunne as its Head of Population Genomics. Personalis believes the population genomics research efforts of today will enable precision medicine in healthcare systems, spanning both germline disease risk and cancer management.

    About the VA Million Veteran Program

    Launched in 2011, the VA MVP is a landmark research effort aimed at better understanding how genetic variations affect health. Up to two-million veterans are expected to enroll in the VA MVP. Data and genetic samples collected through the program are stored securely and made available for studies by authorized researchers, with stringent safeguards in place to protect Veterans' private health information. The VA MVP was enrolling veterans at 63 VA medical centers nationwide prior to the pandemic. The VA's central biorepository is equipped with a state-of-the-art robotic system for DNA extraction and storage and is currently being expanded to support up to 4 million samples. With approximately 850,000 enrollees since 2011, the VA MVP already far exceeds the enrollment numbers of any single VA study or research program in the past, and is in fact one of the largest research cohorts of its kind in the world. The VA MVP provides researchers with a rich resource of genetic, health, lifestyle, and military-exposure data collected from questionnaires, medical records, and genetic analyses. By combining this information into a single database, the VA MVP promises to advance knowledge about the complex links between genes and health. Veterans' privacy and confidentiality are top priorities in the VA MVP, as in all VA research. For more information about the VA MVP, visit www.research.va.gov/MVP. This press release does not imply a Department of Veterans Affairs endorsement, and is neither paid for nor sponsored, in whole or in part, by any element of the United States government.

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to the VA MVP. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. The Personalis Clinical Laboratory is GxP-aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).

    Forward-Looking Statements

    All statements in this press release that are not historical are "forward-looking statements" within the meaning of U.S. securities laws, including statements relating to attributes or advantages of the ImmunoID NeXT Platform, Personalis' services for the VA MVP (including continued receipt of VA MVP samples and continued laboratory operations at the company), the company's business opportunities, leadership or growth, or other future events. Such forward-looking statements involve risks and uncertainties, including those related to the COVID-19 pandemic, that could cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements. Factors that could materially affect actual results can be found in Personalis' filings with the U.S. Securities and Exchange Commission, including the company's most recent reports on Forms 8-K, 10-K and 10-Q, and include those listed under the caption "Risk Factors." Personalis disclaims any obligation to update such forward-looking statements.

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  32. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for population sequencing and cancer, today announced that the company will participate in the EACR Liquid Biopsies Virtual Event, November 18-19, including a poster presentation and satellite symposia.

    The company will showcase both their platforms, ImmunoID NeXT™ and NeXT Liquid Biopsy™.

    ImmunoID NeXT is the first platform to enable comprehensive analysis of both a tumor and its immune microenvironment from a single sample, thus maximizing the biological information that can be generated from a precious tumor specimen.

    NeXT Liquid Biopsy, a first-of-its-kind, high-performance exome-wide liquid biopsy assay, provides a unique ability to evaluate the cancer ecosystem and advance…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for population sequencing and cancer, today announced that the company will participate in the EACR Liquid Biopsies Virtual Event, November 18-19, including a poster presentation and satellite symposia.

    The company will showcase both their platforms, ImmunoID NeXT™ and NeXT Liquid Biopsy™.

    ImmunoID NeXT is the first platform to enable comprehensive analysis of both a tumor and its immune microenvironment from a single sample, thus maximizing the biological information that can be generated from a precious tumor specimen.

    NeXT Liquid Biopsy, a first-of-its-kind, high-performance exome-wide liquid biopsy assay, provides a unique ability to evaluate the cancer ecosystem and advance the development of next-generation therapies. While solid tumor biopsies remain the standard for the interrogation of the cancer genome, the advent of liquid biopsies has demonstrated there can be more to a cancer's genotypic profile than that found in a single tissue biopsy. Therefore, the combination of NeXT Liquid Biopsy and ImmunoID NeXT delivers the most comprehensive view of a cancer's mutational landscape by evaluating both the tissue and blood. NeXT Liquid Biopsy enables investigation into key applications such as spatial and temporal heterogeneity of the tumor, clonal evolution and tumor dynamics in response to therapies, and mechanisms of acquired resistance. In this presentation, we'll highlight data demonstrating the genomic profiling and assay performance enabled by NeXT Liquid Biopsy through the evaluation of reference standards and patient samples.

    Following are details for the Personalis presentations.

    Scientific Poster Presentation

    Poster Number

     

    Title & Presenter

     

    Dates

    40

     

     

    Sensitive detection and monitoring of genetic alterations in circulating cfDNA with an enhanced whole-exome approach

    Presenter: Simo V. Zhang, PhD

     

    NOV 18-19 | Online

    Following are details of an industry-sponsored symposium which will be presented at the meeting.

    Satellite Symposia

    Title

     

    Title & Presenter

     

    Dates

    Sponsored Symposia

     

    NeXT Liquid Biopsy, A High Performance, Exome-Wide Liquid Biopsy Assay to Study Tumor Dynamics

    Presenters: Erin N. Newburn, PhD and Dan Norton, MBA

     

    NOV 18-19 | On Demand

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to the U.S. Department of Veterans Affairs Million Veteran Program (VA MVP). In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. The Personalis Clinical Laboratory is GxP-aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).

    Forward-Looking Statements

    All statements in this press release that are not historical are "forward-looking statements" within the meaning of U.S. securities laws, including statements relating to attributes or advantages of the ImmunoID NeXT Platform, Personalis' services for the VA MVP, the company's business opportunities, leadership or growth, or other future events. Such forward-looking statements involve risks and uncertainties, including those related to the COVID-19 pandemic, that could cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements. Factors that could materially affect actual results can be found in Personalis' filings with the U.S. Securities and Exchange Commission, including the company's most recent reports on Forms 8-K, 10-K and 10-Q, and include those listed under the caption "Risk Factors." Personalis disclaims any obligation to update such forward-looking statements.

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  33. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, today announced that the company will present data from its clinical test - NeXT DxTM - at the virtual AMP Annual Meeting from Nov 16-20, 2020.

    The poster presentation, titled "An exome and transcriptome based NeXT DxTM test enables therapy selection for cancer patients and offers insights into emerging composite biomarkers for immunotherapy" will be presented on Tuesday, Nov 17th between 1-2pm EST. The NeXT Dx test utilizes Personalis' ImmunoID NeXT Platform®, the first platform to enable comprehensive analysis of both a tumor and its immune microenvironment from a single sample. The Personalis NeXT Dx Test provides a diagnostic report to the ordering provider which…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, today announced that the company will present data from its clinical test - NeXT DxTM - at the virtual AMP Annual Meeting from Nov 16-20, 2020.

    The poster presentation, titled "An exome and transcriptome based NeXT DxTM test enables therapy selection for cancer patients and offers insights into emerging composite biomarkers for immunotherapy" will be presented on Tuesday, Nov 17th between 1-2pm EST. The NeXT Dx test utilizes Personalis' ImmunoID NeXT Platform®, the first platform to enable comprehensive analysis of both a tumor and its immune microenvironment from a single sample. The Personalis NeXT Dx Test provides a diagnostic report to the ordering provider which includes genomic alterations identified in 247 cancer-related genes, therapy recommendations, clinical trial matching and results from immunotherapy-related biomarkers such as microsatellite instability (MSI) status and exome-wide tumor mutational burden (TMB). Research data supporting identification of novel biomarkers from tumor exome and transcriptome can be provided upon physician's request.

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to the U.S. Department of Veterans Affairs Million Veteran Program (VA MVP). In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis ImmunoID NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing our biopharmaceutical customers with information on approximately 20,000 human genes, together with the immune system, from a single tissue sample. The Personalis Clinical Laboratory is GxP-aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).

    Forward-Looking Statements

    All statements in this press release that are not historical are "forward-looking statements" within the meaning of U.S. securities laws, including statements relating to attributes or advantages of the ImmunoID NeXT Platform, Personalis' services for the VA MVP, the company's business opportunities, leadership or growth, or other future events. Such forward-looking statements involve risks and uncertainties, including those related to the COVID-19 pandemic, that could cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements. Factors that could materially affect actual results can be found in Personalis' filings with the U.S. Securities and Exchange Commission, including the company's most recent reports on Forms 8-K, 10-K and 10-Q, and include those listed under the caption "Risk Factors." Personalis disclaims any obligation to update such forward-looking statements.

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  34. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for population sequencing and cancer, today announced that the company will participate in the Society for Immunotherapy of Cancer (SITC) Annual Meeting online, November 11-14, including poster presentations on November 11th – 13th.

    The company will showcase ImmunoID NeXT™, the first platform to enable comprehensive analysis of both a tumor and its immune microenvironment from a single sample. ImmunoID NeXT™ can be used to investigate the key tumor and immune-related areas of cancer biology, consolidating multiple oncology biomarker assays into one and maximizing the biological information that can be generated from a precious tumor specimen.

    Following is a list of abstracts that…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for population sequencing and cancer, today announced that the company will participate in the Society for Immunotherapy of Cancer (SITC) Annual Meeting online, November 11-14, including poster presentations on November 11th – 13th.

    The company will showcase ImmunoID NeXT™, the first platform to enable comprehensive analysis of both a tumor and its immune microenvironment from a single sample. ImmunoID NeXT™ can be used to investigate the key tumor and immune-related areas of cancer biology, consolidating multiple oncology biomarker assays into one and maximizing the biological information that can be generated from a precious tumor specimen.

    Following is a list of abstracts that will be presented at the meeting.

    Scientific Poster Presentations

    Poster Number & Category

    Title & Presenter

    Day & Time

    29

    Biomarkers, Immune Monitoring, and Novel Technologies

    Profiling Tumor Circulating Cell-Free DNA with an Enhanced Whole-Exome to Enable Sensitive Assessment of Somatic Mutations

    Presenter: Simo V. Zhang, PhD

    NOV 11 | 5:15 – 5:45 PM EST

    and

    NOV 13 | 4:40 – 5:10 PM EST

    57

    Biomarkers, Immune Monitoring, and Novel Technologies

    Precision neoantigen discovery using novel algorithms and expanded HLA-ligandome datasets

    Presenter: Dattatreya Mellacheruvu, PhD

    NOV 11 | 5:15 – 5:45 PM EST

    and

    NOV 13 | 4:40 – 5:10 PM EST

    67

    Biomarkers, Immune Monitoring, and Novel Technologies

    B-cell receptor heavy chain repertoire profiling using an augmented transcriptome

    Presenter: Eric Levy, Ph.D.

    NOV 11 | 5:15 – 5:45 PM EST

    and

    NOV 13 | 4:40 – 5:10 PM EST

    73

    Biomarkers, Immune Monitoring, and Novel Technologies

    Orthogonally and functionally validated algorithm for detecting HLA loss of heterozygosity

    Presenter: Rachel M. Pyke, PhD

    NOV 11 | 5:15 – 5:45 PM EST

    and

    NOV 13 | 4:40 – 5:10 PM EST

    Following are details of an industry-sponsored symposium which will be presented at the meeting.

    Industry Sponsor Symposium

    Presentation Category

    Title & Presenter

    Day & Time

    Sponsored Symposia

    Maximizing immunotherapy biomarker discovery with a multidimensional tumor immunogenomics platform

    Presenter: Erin N. Newburn, PhD

    NOV 12 | 12:30 – 12:50 PM EST

     

    Personalis will also be exhibiting during the online conference. Representatives will be available to answer questions about the company's cancer immunogenomics services.

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to the U.S. Department of Veterans Affairs Million Veteran Program (VA MVP). In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. The Personalis Clinical Laboratory is GxP-aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).

     

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  35. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for population sequencing and cancer, today reported financial results for the third quarter ended September 30, 2020.

    Third Quarter Highlights

    • Reported record revenues of $19.8 million in the third quarter of 2020 versus $17.2 million in the third quarter of 2019, an increase of 15.5%
    • A total of 39 customers have placed orders for NeXT as of September 30, 2020, with 7 of those customers placing their first orders in the third quarter of 2020
    • Received a new task order with an approximate value of up to $31 million from U.S. Department of Veterans Affairs Million Veterans Program (VA MVP), increasing the contracted to date value to approximately $175 million
    • Achieved milestone…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for population sequencing and cancer, today reported financial results for the third quarter ended September 30, 2020.

    Third Quarter Highlights

    • Reported record revenues of $19.8 million in the third quarter of 2020 versus $17.2 million in the third quarter of 2019, an increase of 15.5%
    • A total of 39 customers have placed orders for NeXT as of September 30, 2020, with 7 of those customers placing their first orders in the third quarter of 2020
    • Received a new task order with an approximate value of up to $31 million from U.S. Department of Veterans Affairs Million Veterans Program (VA MVP), increasing the contracted to date value to approximately $175 million
    • Achieved milestone of completing more than 90,000 whole human genomes sequenced under the VA MVP contract
    • Completed a follow-on public offering and sold 6.6 million shares of common stock at a price of $19.00 per share; received net proceeds of $117.1 million after discounts, fees, and expenses

    "I'm proud to say that we were able to report record revenues once again this quarter, with our team delivering strong execution across both our population sequencing and biopharma businesses, despite the impact from the COVID-19 pandemic. We continued to see strong ordering levels from both our existing and new customers, and year-to-date, our biopharma orders were twice the amount compared with last year," said John West, Chief Executive Officer. "In addition, we further strengthened our balance sheet by raising $117.1 million with an equity financing in the quarter."

    Third Quarter 2020 Financial Results

    Revenues were $19.8 million in the three months ended September 30, 2020, up 15.5% from $17.2 million in the same period of the prior year. In the third quarter, the VA MVP accounted for $14.1 million of the company's total revenues, and the remaining $5.7 million was from biopharmaceutical and all other customers.

    Gross margin was 26.9% for the three months ended September 30, 2020, compared with 32.8% in the same period of the prior year.

    Operating expenses were $15.0 million for the three months ended September 30, 2020, compared with $11.4 million in the same period of the prior year.

    Net loss was $9.5 million for the three months ended September 30, 2020 and net loss per share was $0.27 based on a weighted-average basic and diluted share count of 35.5 million, compared with a net loss of $6.9 million and a net loss per share of $0.22 based on a weighted-average basic and diluted share count of 31.1 million in the same period of the prior year.

    Cash, cash equivalents, and short-term investments were $206.1 million as of September 30, 2020.

    Guidance and COVID-19

    Due to continued uncertainty surrounding the COVID-19 pandemic, Personalis will not provide guidance for fiscal 2020 at this time.

    Webcast and Conference Call Information

    Personalis will host a conference call to discuss the third quarter financial results after market close on Thursday, November 5, 2020 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live over the phone (866) 220-8061 for U.S. callers or (470) 495-9168 for international callers, using conference ID: 9697771. The live webinar can be accessed at https://investors.personalis.com.

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics company, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to the VA MVP. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue or blood sample. The Personalis Clinical Laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from the results predicted, and reported results should not be considered as an indication of future performance. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "hope," "intend," "may," "might," "objective," "ongoing," "plan," "potential," "predict," "project," "should," "target," "will," or "would" or similar expressions and the negatives of those terms. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks, uncertainties and other factors relate to, among others: the timing and pace of new orders from customers; the launch of new products and product features; the timing of tissue and blood sample receipts from customers, which can materially impact revenue quarter over quarter and year over year; whether orders for the NeXT platform and revenues from biopharmaceutical customers will increase; the success of Personalis' collaborations and partnerships; the success of the company's international expansion plans; the evolution of cancer therapies and market adoption of the company's services; the company's expectations regarding future performance; and the COVID-19 pandemic, which may significantly impact the company's business and operations and the business and operations of our customers. In addition, other potential risks and uncertainties that could cause actual results to differ from the results predicted include, among others, those risks and uncertainties included under the captions "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Quarterly Report on Form 10-Q for the period ended September 30, 2020, that will be filed following this earnings release. All information provided in this release is as of the date of this press release, and any forward-looking statements contained herein are based on assumptions that we believe to be reasonable as of this date. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. Personalis undertakes no duty to update this information unless required by law.

    PERSONALIS, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)

    (in thousands, except share and per share data)

     

     

     

    Three Months Ended

     

     

    Nine Months Ended

     

     

     

    September 30,

     

     

    September 30,

     

     

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

    Revenues

     

    $

    19,816

     

     

    $

    17,153

     

     

    $

    58,472

     

     

    $

    47,053

     

    Costs and expenses

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Costs of revenues

     

     

    14,483

     

     

     

    11,524

     

     

     

    44,428

     

     

     

    31,538

     

    Research and development

     

     

    7,193

     

     

     

    5,303

     

     

     

    20,048

     

     

     

    15,045

     

    Selling, general and administrative

     

     

    7,793

     

     

     

    6,056

     

     

     

    22,772

     

     

     

    15,692

     

    Total costs and expenses

     

     

    29,469

     

     

     

    22,883

     

     

     

    87,248

     

     

     

    62,275

     

    Loss from operations

     

     

    (9,653

    )

     

     

    (5,730

    )

     

     

    (28,776

    )

     

     

    (15,222

    )

    Interest income

     

     

    117

     

     

     

    756

     

     

     

    873

     

     

     

    1,040

     

    Interest expense

     

     

     

     

     

    (204

    )

     

     

    (2

    )

     

     

    (1,133

    )

    Loss on debt extinguishment

     

     

     

     

     

    (1,704

    )

     

     

     

     

     

    (1,704

    )

    Other (expense) income, net

     

     

    (4

    )

     

     

    (2

    )

     

     

    5

     

     

     

    (1,415

    )

    Loss before income taxes

     

     

    (9,540

    )

     

     

    (6,884

    )

     

     

    (27,900

    )

     

     

    (18,434

    )

    Provision for income taxes

     

     

    (5

    )

     

     

    (1

    )

     

     

    (39

    )

     

     

    (5

    )

    Net loss

     

    $

    (9,545

    )

     

    $

    (6,885

    )

     

    $

    (27,939

    )

     

    $

    (18,439

    )

    Net loss per share, basic and diluted

     

    $

    (0.27

    )

     

    $

    (0.22

    )

     

    $

    (0.85

    )

     

    $

    (1.35

    )

    Weighted-average shares outstanding, basic and diluted

     

     

    35,460,092

     

     

     

    31,133,683

     

     

     

    32,845,583

     

     

     

    13,613,444

     

    PERSONALIS, INC.

    SUPPLEMENTAL REVENUE INFORMATION (unaudited)

    (in thousands)

     

     

     

    Three Months Ended

    September 30,

     

     

    Nine Months Ended

    September 30,

     

     

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

    VA MVP

     

    $

    14,092

     

     

    $

    12,912

     

     

    $

    43,598

     

     

    $

    29,791

     

    All other customers

     

     

    5,724

     

     

     

    4,241

     

     

     

    14,874

     

     

     

    17,262

     

    Total

     

    $

    19,816

     

     

    $

    17,153

     

     

    $

    58,472

     

     

    $

    47,053

     

    PERSONALIS, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited)

    (in thousands, except share and per share data)

     

     

     

    September 30,

     

     

    December 31,

     

     

     

    2020

     

     

    2019

     

    Assets

     

     

     

     

     

     

     

     

    Current assets

     

     

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    133,245

     

     

    $

    55,046

     

    Short-term investments

     

     

    72,818

     

     

     

    73,243

     

    Accounts receivable, net

     

     

    5,903

     

     

     

    3,300

     

    Inventory and other deferred costs

     

     

    6,268

     

     

     

    4,606

     

    Prepaid expenses and other current assets

     

     

    5,359

     

     

     

    3,383

     

    Total current assets

     

     

    223,593

     

     

     

    139,578

     

    Property and equipment, net

     

     

    12,735

     

     

     

    14,106

     

    Operating lease right-of-use assets

     

     

    10,632

     

     

     

    1,845

     

    Other long-term assets

     

     

    1,852

     

     

     

    1,762

     

    Total assets

     

    $